The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

NCT05082337 | Completed

• 1 other identifier: PRT-2015-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.

Conditions

Aortic Valve Disease; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Hemodynamic Measurement

Outcome Measures

Primary Outcomes (6)

• Presence of Major complications

  Presence of major complications related to the SAVVY guidewire including (i) guidewire kink hindering or preventing the advancement of the transcatheter valve system

  Periprocedural

• Presence of Major vascular complications

  Major vascular complications related to the SAVVY guidewire are defined as stroke, bleeding or left ventricular perforation

  Periprocedural

• Number of transcatheter valve malpositioning

  Pacing capture failure translating into valve malpositioning. Valve malpositiong will be evaluated by a landing site to low or too high, leading to hemodynamically unfavorable results.

  Periprocedural

• Number of valve embolization

  Pacing capture failure translating into valve embolization

  Periprocedural

• Number of effective rapid pacing run

  Effective rapid pacing will be defined as an adequate ventricular pacing capture for a minimum of 10 seconds, with no capture loss, and leading to a reduction of aortic pressure of at least 50%, with/or a systolic pressure value \<60 mmHg. Efficacy will be assessed by the physician.

  Periprocedural

• Number of accurate ventricular pressure

  Accurate ventricular pressure will be defines as a pressure wire measurements similar (differences \<5 mmHg) to those obtained simultaneously with a pigtail catheter in the same cavity or vascular segment (differences \<5 mmHg in SBP, differences \<5 mmHg in LVEDP).

  Periprocedural

Study Arms (1)

Guidewire

EXPERIMENTAL

The SAVVY guidewire will be used in all TAVR procedures of patients included in the study

Device: SAVVY guidewire

Interventions

SAVVY guidewire DEVICE

The SAVVY guidewire will be used for rapid pacing runs, valve delivery and for left ventricular pressure measurements pre- and post-THV deployment

Guidewire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe symptomatic AS undergoing a TAVR procedure.

You may not qualify if:

• Failure to provide signed informed consent.
• Extremely calcified aortic valve (Agatston score \>3000 AU)
• Extremely horizontal aorta.
• Severe septal hypertrophy (interventricular septum \>15 mm as measured by TTE).
• Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta.
• Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life threatening complication.
• Young patients (\<18 Years) and pregnant women

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead
• Institut de Cardiologie de Montréal: collaborator

Study Sites (2)

ICM

Montreal, Quebec, H1T 1C8, Canada

Location

IUCPQ

Québec, G1V 4G5, Canada

Location

Related Publications (9)

• Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.

  PMID: 28298458 BACKGROUND

• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

  PMID: 30883053 BACKGROUND

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

  PMID: 30883058 BACKGROUND

• Genereux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, van Mieghem NM, Alu MC, Serruys PW, Kappetein AP, Leon MB. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature. J Am Coll Cardiol. 2013 Mar 19;61(11):1125-36. doi: 10.1016/j.jacc.2012.08.1039. Epub 2013 Jan 30.

  PMID: 23375925 BACKGROUND

• Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013 Apr 16;61(15):1585-95. doi: 10.1016/j.jacc.2013.01.047.

  PMID: 23500308 BACKGROUND

• Nishimura RA, Carabello BA. Hemodynamics in the cardiac catheterization laboratory of the 21st century. Circulation. 2012 May 1;125(17):2138-50. doi: 10.1161/CIRCULATIONAHA.111.060319. No abstract available.

  PMID: 22547754 BACKGROUND

• Pibarot P, Hahn RT, Weissman NJ, Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging. 2015 Mar;8(3):340-360. doi: 10.1016/j.jcmg.2015.01.008.

  PMID: 25772838 BACKGROUND

• Liao YB, Deng XX, Meng Y, Zhao ZG, Xiong TY, Meng XJ, Zuo ZL, Li YJ, Cao JY, Xu YN, Chen M, Feng Y. Predictors and outcome of acute kidney injury after transcatheter aortic valve implantation: a systematic review and meta-analysis. EuroIntervention. 2017 Apr 20;12(17):2067-2074. doi: 10.4244/EIJ-D-15-00254.

  PMID: 27890858 BACKGROUND

• Kamioka N, Wells J, Keegan P, Lerakis S, Binongo J, Corrigan F, Condado J, Patel A, Forcillo J, Ogburn L, Dong A, Caughron H, Simone A, Leshnower B, Devireddy C, Mavromatis K, Guyton R, Stewart J, Thourani V, Block PC, Babaliaros V. Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018 Jan 22;11(2):107-115. doi: 10.1016/j.jcin.2017.10.021.

  PMID: 29348004 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patient with severe symptomatic aortic stenosis with a clinical indication for TAVR according to the Heart Team criteria will be treated with an approved aortic valve (balloon-expandable or self-expandable aortic valve) and the SAVVY guidewire will be used for the rapid pacing runs and ventricular pressure measurements.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 18, 2021
• Study Start: October 8, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)