Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study)

NCT01835028 | Unknown

• 1 other identifier: MOP-57745
• Study Type: observational
• Target: 320
• Locations: 6 countries
• Sites: 11

Brief Summary

Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging encountered in patients with valvular heart disease. Although, CLF-LG AS is recognized has an important clinical entity, current ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management of these patients . PLF-LG AS is a new entity recently described by our group, which is characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a restrictive physiology leading to impaired LV filling, altered myocardial function, and a low-flow state. Up to recently, this entity was often misdiagnosed, leading to underestimation of AS severity and inappropriate delays for aortic valve replacement surgery (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to distinguish between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to accurately quantify the extent of myocardial impairment. Unfortunately, the traditional resting and stress echocardiographic parameters currently used to assess the severity of valvular and myocardial dysfunction in patients with LF-LG AS are far from being optimal, and as a consequence, quantification of disease severity and therapeutic management may not be appropriate in a substantial proportion of these patients. THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and biomarkers to improve the assessment of stenosis severity and myocardial impairment, the risk-stratification, and the clinical decision making in patients with LF-LG AS and to assess the impact of the different therapeutic strategies on patient outcomes.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Stenosis; Low Flow; Low Gradient; Left Ventricle; Echocardiography, Doppler

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  Patients will be followed for 5 years, with an average of 3.5 years

Secondary Outcomes (4)

• 30-day mortality (for patients treated by SAVR or TAVR)

  Patients will be followed for 5 years, with an average of 3.5 years

• cardiovascular mortality

  Patients will be followed for 5 years, with an average of 3.5 years

• new major cardiovascular events as defined by VARC: myocardial infarction, stroke, vascular complications, and re-hospitalization for heart failure composite end-point of cardiovascular mortality and hospitalization for heart failure

  Patients will be followed for 5 years, with an average of 3.5 years

• composite end-point of cardiovascular mortality and hospitalization for heart failure

  Patients will be followed for 5 years, with an average of 3.5 years

Other Outcomes (3)

• (1) Stenosis severity: We will use the weight and calcification of the valve explanted at the time of SAVR as a flow-independent marker of stenosis severity

  Patients will be followed for 5 years, with an average of 3.5 years

• Hemodynamic (LV function) outcome: The outcome variables will be the changes during follow-up in resting and peak stress values of stroke volume, LVEF, longitudinal strain and plasma levels of BNP; LV flow reserve; LV contractile reserve

  Patients will be followed for 5 years, with an average of 3.5 years

• Functional outcome: Another important objective of treatment is to improve the patient's functional status and quality of life. The outcome variables will be the changes in Duke Activity Score Index and the 6-min walk test distance during follow-up

  Patients will be followed for 5 years, with an average of 3.5 years

Study Arms (2)

Classical Low-Flow, Low-Gradient AS

Observational study in patients with Classical Low-Flow, Low-Gradient Aortic Stenosis and Low LV Ejection Fraction undergoing surgical aortic valve replacement, transcatheter aortic valve replacement, or conservative management: I- Baseline visit: Medical history, physical / functional evaluation, blood biomarkers, resting echocardiography, stress echocardiography, aortic valve calcium scoring by computed tomography, myocardial fibrosis by magnetic resonance imaging II- Follow-up: clinical outcomes, physical / functional evaluation, echocardiography, blood biomarkers

Other: Echocardiography; Other: Computed tomography; Other: Magnetic resonance imaging; Other: Blood biomarkers; Other: Stress echocardiography

Paradoxical Low-Flow, Low-Gradient AS

Observational study in patients with Paradoxical Low-Flow, Low-Gradient Aortic Stenosis and Preserved LV Ejection Fraction undergoing surgical aortic valve replacement, transcatheter aortic valve replacement, or conservative management: I- Baseline visit: Medical history, physical / functional evaluation, blood biomarkers, resting echocardiography, stress echocardiography, aortic valve calcium scoring by computed tomography, myocardial fibrosis by magnetic resonance imaging II- Follow-up: clinical outcomes, physical / functional evaluation, echocardiography, blood biomarkers

Other: Echocardiography; Other: Computed tomography; Other: Magnetic resonance imaging; Other: Blood biomarkers; Other: Stress echocardiography

Interventions

Echocardiography OTHER

Observational Study using Imaging and Biomarkers

Classical Low-Flow, Low-Gradient AS; Paradoxical Low-Flow, Low-Gradient AS

Computed tomography OTHER

Observational Study using Imaging and Biomarkers

Classical Low-Flow, Low-Gradient AS; Paradoxical Low-Flow, Low-Gradient AS

Magnetic resonance imaging OTHER

Observational Study using Imaging and Biomarkers

Classical Low-Flow, Low-Gradient AS; Paradoxical Low-Flow, Low-Gradient AS

Blood biomarkers OTHER

Observational Study using Imaging and Biomarkers

Classical Low-Flow, Low-Gradient AS; Paradoxical Low-Flow, Low-Gradient AS

Stress echocardiography OTHER

Observational Study using Imaging and Biomarkers

Classical Low-Flow, Low-Gradient AS; Paradoxical Low-Flow, Low-Gradient AS

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with moderate to severe aortic stenosis and Low Fow Low Gradiwnt , with Low and preserved Ejection Fraction wil be selected at primary care clinic

You may qualify if:

• LVEF≤ 40%
• Indexed aortic valve area (AVA) ≤ 0.6 cm²/m²
• Mean transvalvular gradient \< 40 mmHg

You may not qualify if:

• Pregnant or lactating women
• advanced renal failure
• tumor with metastasis

Sponsors & Collaborators

• Laval University: lead
• University Hospital, Brest: collaborator

Study Sites (11)

Mayo Clinic

Rochester, Minnesota, United States

NOT YET RECRUITING

Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

NOT YET RECRUITING

Viena General Hospital

Vienna, Austria

RECRUITING

CHU Start Tilman

Liège, Belgium

NOT YET RECRUITING

Ottawa Heart Institute University

Ottawa, Ontario, Canada

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

RECRUITING

St Paul's Hospital, Vancouver

Vancouver, Canada

RECRUITING

Hôpital La Timone

Marseille, France

NOT YET RECRUITING

Hôpital Bichat

Paris, France

NOT YET RECRUITING

CHU, Rennes

Rennes, France

NOT YET RECRUITING

University Hospital

Münster, Germany

RECRUITING

Related Publications (41)

• Blais C, Dumesnil JG, Baillot R, Simard S, Doyle D, Pibarot P. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement. Circulation. 2003 Aug 26;108(8):983-8. doi: 10.1161/01.CIR.0000085167.67105.32. Epub 2003 Aug 11.

  PMID: 12912812 BACKGROUND

• Mohty D, Dumesnil JG, Echahidi N, Mathieu P, Dagenais F, Voisine P, Pibarot P. Impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: influence of age, obesity, and left ventricular dysfunction. J Am Coll Cardiol. 2009 Jan 6;53(1):39-47. doi: 10.1016/j.jacc.2008.09.022.

  PMID: 19118723 BACKGROUND

• Hachicha Z, Dumesnil JG, Bogaty P, Pibarot P. Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival. Circulation. 2007 Jun 5;115(22):2856-64. doi: 10.1161/CIRCULATIONAHA.106.668681. Epub 2007 May 28.

  PMID: 17533183 BACKGROUND

• Hachicha Z, Dumesnil JG, Pibarot P. Usefulness of the valvuloarterial impedance to predict adverse outcome in asymptomatic aortic stenosis. J Am Coll Cardiol. 2009 Sep 8;54(11):1003-11. doi: 10.1016/j.jacc.2009.04.079.

  PMID: 19729117 BACKGROUND

• Pibarot P, Dumesnil JG. Low-flow, low-gradient aortic stenosis with normal and depressed left ventricular ejection fraction. J Am Coll Cardiol. 2012 Nov 6;60(19):1845-53. doi: 10.1016/j.jacc.2012.06.051. Epub 2012 Oct 10.

  PMID: 23062546 BACKGROUND

• Dumesnil JG, Pibarot P, Carabello B. Paradoxical low flow and/or low gradient severe aortic stenosis despite preserved left ventricular ejection fraction: implications for diagnosis and treatment. Eur Heart J. 2010 Feb;31(3):281-9. doi: 10.1093/eurheartj/ehp361. Epub 2009 Sep 8.

  PMID: 19737801 BACKGROUND

• Dumesnil JG, Pibarot P. Evaluation of aortic stenosis severity: new challenges, new solutions. J Am Soc Echocardiogr. 2011 Sep;24(9):992-4. doi: 10.1016/j.echo.2011.07.011. No abstract available.

  PMID: 21867870 BACKGROUND

• Pibarot P, Dumesnil JG. Assessment of aortic stenosis severity: when the gradient does not fit with the valve area. Heart. 2010 Sep;96(18):1431-3. doi: 10.1136/hrt.2010.195149. No abstract available.

  PMID: 20813724 BACKGROUND

• Pibarot P, Dumesnil JG. Paradoxical low-flow, low-gradient aortic stenosis adding new pieces to the puzzle. J Am Coll Cardiol. 2011 Jul 19;58(4):413-5. doi: 10.1016/j.jacc.2011.01.057. No abstract available.

  PMID: 21757119 BACKGROUND

• Pibarot P, Dumesnil JG. Improving assessment of aortic stenosis. J Am Coll Cardiol. 2012 Jul 17;60(3):169-80. doi: 10.1016/j.jacc.2011.11.078.

  PMID: 22789881 BACKGROUND

• Picano E, Pibarot P, Lancellotti P, Monin JL, Bonow RO. The emerging role of exercise testing and stress echocardiography in valvular heart disease. J Am Coll Cardiol. 2009 Dec 8;54(24):2251-60. doi: 10.1016/j.jacc.2009.07.046.

  PMID: 19958961 BACKGROUND

• Rodriguez-Gabella T, Nombela-Franco L, Auffret V, Asmarats L, Islas F, Maes F, Ferreira-Neto AN, Paradis JM, Dumont E, Cote M, Jimenez-Quevedo P, Macaya C, Pibarot P, Rodes-Cabau J. Transcatheter Aortic Valve Implantation in Patients With Paradoxical Low-Flow, Low-Gradient Aortic Stenosis. Am J Cardiol. 2018 Aug 15;122(4):625-632. doi: 10.1016/j.amjcard.2018.04.044. Epub 2018 May 17.

  PMID: 30064863 BACKGROUND

• Annabi MS, Clisson M, Clavel MA, Pibarot P. Workup and Management of Patients With Paradoxical Low-Flow, Low-Gradient Aortic Stenosis. Curr Treat Options Cardiovasc Med. 2018 May 2;20(6):49. doi: 10.1007/s11936-018-0642-y.

  PMID: 29721704 BACKGROUND

• Ribeiro HB, Lerakis S, Gilard M, Cavalcante JL, Makkar R, Herrmann HC, Windecker S, Enriquez-Sarano M, Cheema AN, Nombela-Franco L, Amat-Santos I, Munoz-Garcia AJ, Garcia Del Blanco B, Zajarias A, Lisko JC, Hayek S, Babaliaros V, Le Ven F, Gleason TG, Chakravarty T, Szeto WY, Clavel MA, de Agustin A, Serra V, Schindler JT, Dahou A, Puri R, Pelletier-Beaumont E, Cote M, Pibarot P, Rodes-Cabau J. Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry. J Am Coll Cardiol. 2018 Mar 27;71(12):1297-1308. doi: 10.1016/j.jacc.2018.01.054.

  PMID: 29566812 BACKGROUND

• Annabi MS, Touboul E, Dahou A, Burwash IG, Bergler-Klein J, Enriquez-Sarano M, Orwat S, Baumgartner H, Mascherbauer J, Mundigler G, Cavalcante JL, Larose E, Pibarot P, Clavel MA. Dobutamine Stress Echocardiography for Management of Low-Flow, Low-Gradient Aortic Stenosis. J Am Coll Cardiol. 2018 Feb 6;71(5):475-485. doi: 10.1016/j.jacc.2017.11.052.

  PMID: 29406851 BACKGROUND

• Dahou A, Clavel MA, Dumesnil JG, Capoulade R, Ribeiro HB, O'Connor K, Mathieu P, Beaudoin J, Larose E, Rodes-Cabau J, Pibarot P. Impact of AVR on LV Remodeling and Function in Paradoxical Low-Flow, Low-Gradient Aortic Stenosis With Preserved LVEF. JACC Cardiovasc Imaging. 2017 Jan;10(1):88-89. doi: 10.1016/j.jcmg.2016.07.009. Epub 2016 Nov 9. No abstract available.

  PMID: 27838305 BACKGROUND

• Dahou A, Toubal O, Clavel MA, Beaudoin J, Magne J, Mathieu P, Philippon F, Dumesnil JG, Puri R, Ribeiro HB, Larose E, Rodes-Cabau J, Pibarot P. Relationship Between QT Interval and Outcome in Low-Flow Low-Gradient Aortic Stenosis With Low Left Ventricular Ejection Fraction. J Am Heart Assoc. 2016 Oct 20;5(10):e003980. doi: 10.1161/JAHA.116.003980.

  PMID: 27792655 BACKGROUND

• Dahou A, Clavel MA, Capoulade R, Bartko PE, Magne J, Mundigler G, Bergler-Klein J, Burwash I, Mascherbauer J, Ribeiro HB, O'Connor K, Baumgartner H, Senechal M, Dumesnil JG, Rosenhek R, Mathieu P, Larose E, Rodes-Cabau J, Pibarot P. Right ventricular longitudinal strain for risk stratification in low-flow, low-gradient aortic stenosis with low ejection fraction. Heart. 2016 Apr;102(7):548-54. doi: 10.1136/heartjnl-2015-308309. Epub 2016 Jan 13.

  PMID: 26762240 BACKGROUND

• Dayan V, Vignolo G, Magne J, Clavel MA, Mohty D, Pibarot P. Outcome and Impact of Aortic Valve Replacement in Patients With Preserved LVEF and Low-Gradient Aortic Stenosis. J Am Coll Cardiol. 2015 Dec 15;66(23):2594-2603. doi: 10.1016/j.jacc.2015.09.076.

  PMID: 26670058 BACKGROUND

• Le Ven F, Thebault C, Dahou A, Ribeiro HB, Capoulade R, Mahjoub H, Urena M, Nombela-Franco L, Allende Carrera R, Clavel MA, Dumont E, Dumesnil J, De Larochelliere R, Rodes-Cabau J, Pibarot P. Evolution and prognostic impact of low flow after transcatheter aortic valve replacement. Heart. 2015 Aug;101(15):1196-203. doi: 10.1136/heartjnl-2014-307067. Epub 2015 May 21.

  PMID: 25999587 BACKGROUND

• Dahou A, Magne J, Clavel MA, Capoulade R, Bartko PE, Bergler-Klein J, Senechal M, Mundigler G, Burwash I, Ribeiro HB, O'Connor K, Mathieu P, Baumgartner H, Dumesnil JG, Rosenhek R, Larose E, Rodes-Cabau J, Pibarot P. Tricuspid Regurgitation Is Associated With Increased Risk of Mortality in Patients With Low-Flow Low-Gradient Aortic Stenosis and Reduced Ejection Fraction: Results of the Multicenter TOPAS Study (True or Pseudo-Severe Aortic Stenosis). JACC Cardiovasc Interv. 2015 Apr 20;8(4):588-96. doi: 10.1016/j.jcin.2014.08.019. Epub 2015 Mar 26.

  PMID: 25819185 BACKGROUND

• Dahou A, Bartko PE, Capoulade R, Clavel MA, Mundigler G, Grondin SL, Bergler-Klein J, Burwash I, Dumesnil JG, Senechal M, O'Connor K, Baumgartner H, Pibarot P. Usefulness of global left ventricular longitudinal strain for risk stratification in low ejection fraction, low-gradient aortic stenosis: results from the multicenter True or Pseudo-Severe Aortic Stenosis study. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002117. doi: 10.1161/CIRCIMAGING.114.002117.

  PMID: 25681417 BACKGROUND

• Clavel MA, Berthelot-Richer M, Le Ven F, Capoulade R, Dahou A, Dumesnil JG, Mathieu P, Pibarot P. Impact of classic and paradoxical low flow on survival after aortic valve replacement for severe aortic stenosis. J Am Coll Cardiol. 2015 Feb 24;65(7):645-53. doi: 10.1016/j.jacc.2014.11.047.

  PMID: 25677424 BACKGROUND

• Mohty D, Boulogne C, Magne J, Pibarot P, Echahidi N, Cornu E, Dumesnil J, Laskar M, Virot P, Aboyans V. Prevalence and long-term outcome of aortic prosthesis-patient mismatch in patients with paradoxical low-flow severe aortic stenosis. Circulation. 2014 Sep 9;130(11 Suppl 1):S25-31. doi: 10.1161/CIRCULATIONAHA.113.007819.

  PMID: 25200051 BACKGROUND

• Clavel MA, Cote N, Mathieu P, Dumesnil JG, Audet A, Pepin A, Couture C, Fournier D, Trahan S, Page S, Pibarot P. Paradoxical low-flow, low-gradient aortic stenosis despite preserved left ventricular ejection fraction: new insights from weights of operatively excised aortic valves. Eur Heart J. 2014 Oct 7;35(38):2655-62. doi: 10.1093/eurheartj/ehu152. Epub 2014 Apr 21.

  PMID: 24755006 BACKGROUND

• Mohty D, Magne J, Deltreuil M, Aboyans V, Echahidi N, Cassat C, Pibarot P, Laskar M, Virot P. Outcome and impact of surgery in paradoxical low-flow, low-gradient severe aortic stenosis and preserved left ventricular ejection fraction: a cardiac catheterization study. Circulation. 2013 Sep 10;128(11 Suppl 1):S235-42. doi: 10.1161/CIRCULATIONAHA.112.000031.

  PMID: 24030412 BACKGROUND

• Le Ven F, Freeman M, Webb J, Clavel MA, Wheeler M, Dumont E, Thompson C, De Larochelliere R, Moss R, Doyle D, Ribeiro HB, Urena M, Nombela-Franco L, Rodes-Cabau J, Pibarot P. Impact of low flow on the outcome of high-risk patients undergoing transcatheter aortic valve replacement. J Am Coll Cardiol. 2013 Aug 27;62(9):782-8. doi: 10.1016/j.jacc.2013.05.044. Epub 2013 Jun 12.

  PMID: 23770162 BACKGROUND

• Clavel MA, Ennezat PV, Marechaux S, Dumesnil JG, Capoulade R, Hachicha Z, Mathieu P, Bellouin A, Bergeron S, Meimoun P, Arsenault M, Le Tourneau T, Pasquet A, Couture C, Pibarot P. Stress echocardiography to assess stenosis severity and predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis and preserved LVEF. JACC Cardiovasc Imaging. 2013 Feb;6(2):175-83. doi: 10.1016/j.jcmg.2012.10.015.

  PMID: 23489531 BACKGROUND

• Williams TE, O'Day DM, Head WS, Robinson RD. Measurements of antifungal levels in corneal tissue: a simplified bioassay for amphotericin B. Graefes Arch Clin Exp Ophthalmol. 1990;228(6):538-40. doi: 10.1007/BF00918487.

  PMID: 2265769 BACKGROUND

• Clavel MA, Burwash IG, Mundigler G, Dumesnil JG, Baumgartner H, Bergler-Klein J, Senechal M, Mathieu P, Couture C, Beanlands R, Pibarot P. Validation of conventional and simplified methods to calculate projected valve area at normal flow rate in patients with low flow, low gradient aortic stenosis: the multicenter TOPAS (True or Pseudo Severe Aortic Stenosis) study. J Am Soc Echocardiogr. 2010 Apr;23(4):380-6. doi: 10.1016/j.echo.2010.02.002.

  PMID: 20362927 BACKGROUND

• Blais C, Burwash IG, Mundigler G, Dumesnil JG, Loho N, Rader F, Baumgartner H, Beanlands RS, Chayer B, Kadem L, Garcia D, Durand LG, Pibarot P. Projected valve area at normal flow rate improves the assessment of stenosis severity in patients with low-flow, low-gradient aortic stenosis: the multicenter TOPAS (Truly or Pseudo-Severe Aortic Stenosis) study. Circulation. 2006 Feb 7;113(5):711-21. doi: 10.1161/CIRCULATIONAHA.105.557678.

  PMID: 16461844 RESULT

• Clavel MA, Webb JG, Rodes-Cabau J, Masson JB, Dumont E, De Larochelliere R, Doyle D, Bergeron S, Baumgartner H, Burwash IG, Dumesnil JG, Mundigler G, Moss R, Kempny A, Bagur R, Bergler-Klein J, Gurvitch R, Mathieu P, Pibarot P. Comparison between transcatheter and surgical prosthetic valve implantation in patients with severe aortic stenosis and reduced left ventricular ejection fraction. Circulation. 2010 Nov 9;122(19):1928-36. doi: 10.1161/CIRCULATIONAHA.109.929893. Epub 2010 Oct 25.

  PMID: 20975002 RESULT

• Clavel MA, Fuchs C, Burwash IG, Mundigler G, Dumesnil JG, Baumgartner H, Bergler-Klein J, Beanlands RS, Mathieu P, Magne J, Pibarot P. Predictors of outcomes in low-flow, low-gradient aortic stenosis: results of the multicenter TOPAS Study. Circulation. 2008 Sep 30;118(14 Suppl):S234-42. doi: 10.1161/CIRCULATIONAHA.107.757427.

  PMID: 18824760 RESULT

• Bergler-Klein J, Mundigler G, Pibarot P, Burwash IG, Dumesnil JG, Blais C, Fuchs C, Mohty D, Beanlands RS, Hachicha Z, Walter-Publig N, Rader F, Baumgartner H. B-type natriuretic peptide in low-flow, low-gradient aortic stenosis: relationship to hemodynamics and clinical outcome: results from the Multicenter Truly or Pseudo-Severe Aortic Stenosis (TOPAS) study. Circulation. 2007 Jun 5;115(22):2848-55. doi: 10.1161/CIRCULATIONAHA.106.654210. Epub 2007 May 21.

  PMID: 17515464 RESULT

• Burwash IG, Lortie M, Pibarot P, de Kemp RA, Graf S, Mundigler G, Khorsand A, Blais C, Baumgartner H, Dumesnil JG, Hachicha Z, DaSilva J, Beanlands RS. Myocardial blood flow in patients with low-flow, low-gradient aortic stenosis: differences between true and pseudo-severe aortic stenosis. Results from the multicentre TOPAS (Truly or Pseudo-Severe Aortic Stenosis) study. Heart. 2008 Dec;94(12):1627-33. doi: 10.1136/hrt.2007.135475. Epub 2008 Apr 1.

  PMID: 18381378 RESULT

• Clavel MA, Webb JG, Pibarot P, Altwegg L, Dumont E, Thompson C, De Larochelliere R, Doyle D, Masson JB, Bergeron S, Bertrand OF, Rodes-Cabau J. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis. J Am Coll Cardiol. 2009 May 19;53(20):1883-91. doi: 10.1016/j.jacc.2009.01.060.

  PMID: 19442889 RESULT

• Clavel MA, Rodes-Cabau J, Dumont E, Bagur R, Bergeron S, De Larochelliere R, Doyle D, Larose E, Dumesnil JG, Pibarot P. Validation and characterization of transcatheter aortic valve effective orifice area measured by Doppler echocardiography. JACC Cardiovasc Imaging. 2011 Oct;4(10):1053-62. doi: 10.1016/j.jcmg.2011.06.021.

  PMID: 21999863 RESULT

• Clavel MA, Dumesnil JG, Capoulade R, Mathieu P, Senechal M, Pibarot P. Outcome of patients with aortic stenosis, small valve area, and low-flow, low-gradient despite preserved left ventricular ejection fraction. J Am Coll Cardiol. 2012 Oct 2;60(14):1259-67. doi: 10.1016/j.jacc.2011.12.054. Epub 2012 May 30.

  PMID: 22657269 RESULT

• Galli E, Le Ven F, Coisne A, Sportouch C, Le Tourneau T, Lavie-Badie Y, Bernard A, Eicher JC, Dreyfus J, Ternacle J, Baleynaud S, Auffret V, Le Pabic E, Pibarot P, Oger E, Donal E. Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial). Heart. 2024 Sep 25;110(20):1223-1230. doi: 10.1136/heartjnl-2024-324224.

  PMID: 39209438 DERIVED

• Annabi MS, Cote N, Dahou A, Bartko PE, Bergler-Klein J, Burwash IG, Orwat S, Baumgartner H, Mascherbauer J, Mundigler G, Fukui M, Cavalcante J, Ribeiro HB, Rodes-Cabau J, Clavel MA, Pibarot P. Comparison of Early Surgical or Transcatheter Aortic Valve Replacement Versus Conservative Management in Low-Flow, Low-Gradient Aortic Stenosis Using Inverse Probability of Treatment Weighting: Results From the TOPAS Prospective Observational Cohort Study. J Am Heart Assoc. 2020 Dec 15;9(24):e017870. doi: 10.1161/JAHA.120.017870. Epub 2020 Dec 8.

  PMID: 33289422 DERIVED

• Dahou A, Clavel MA, Capoulade R, O'Connor K, Ribeiro HB, Cote N, Le Ven F, Rodes-Cabau J, Dumesnil JG, Mathieu P, Pibarot P. B-Type Natriuretic Peptide and High-Sensitivity Cardiac Troponin for Risk Stratification in Low-Flow, Low-Gradient Aortic Stenosis: A Substudy of the TOPAS Study. JACC Cardiovasc Imaging. 2018 Jul;11(7):939-947. doi: 10.1016/j.jcmg.2017.06.018. Epub 2017 Oct 5.

  PMID: 28917673 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (lithium-heparin, EDTA), Tissue (explanted aortic valves)

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Philippe Pibarot, DVM, PHD

CONTACT

418-656-8711; Philippe.Pibarot@med.ulaval.ca

Abdellaziz Dahou, MD

CONTACT

418-656-8711; abdellaziz.dahou@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: June 1, 2002
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (2); AU (1); CA (3); BE (1); FR (3); DE (1)