Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance

NCT04156295 | Completed

• 1 other identifier: 248271
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).

Conditions

Mitral Regurgitation; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (7)

• Change in LV size

  Change in LV size by two dimensional linear dimension (cm)

  Within 3-6 months post intervention

• Change in LV volume (2D)

  Change in LV volume by Simpson's Biplane method (mL)

  Within 3-6 months post intervention

• Change in LV volume (3D)

  Change in LV volume by 3D volume method (mL)

  Within 3-6 months post intervention

• Change in LV systolic function (2D EF)

  Change in LV systolic function by Ejection Fraction by 2D method (%)

  Within 3-6 months post intervention

• Change in LV systolic function (3D EF)

  Change in LV systolic function by Ejection Fraction by 3D method (%)

  Within 3-6 months post intervention

• Change in LV systolic function (GLS)

  Change in LV systolic function by Global Longitudinal strain (GLS) by 3D method

  Within 3-6 months post intervention

• Change in LV systolic function (EF1)

  Change in LV systolic function by First Phase Ejection Fraction (%)

  Within 3-6 months post intervention

Secondary Outcomes (11)

• Change in clinical outcomes - symptoms

  Within 3-6 months post intervention

• Change in clinical outcomes - NYHA class

  Within 3-6 months post intervention

• Change in clinical outcomes - Quality of Life

  Within 3-6 months post intervention

• Change in clinical outcomes - 6MWT

  Within 3-6 months post intervention

• Change in clinical outcomes - NT Pro BNP

  Within 3-6 months post intervention

Eligibility Criteria

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

Study Population

This study will be performed across two sites, namely Guy's and St Thomas' and King' College Hospitals. Patients will be recruited based on referral to GSTT or KCH, a diagnosis of mitral valve disease and clinical eligibility for percutaneous mitral valve intervention.

You may qualify if:

• years or older
• At least moderate to severe symptomatic mitral regurgitation
• Life expectancy greater than 1 year post intervention
• Able to give informed consent

You may not qualify if:

• \. Patient not eligible for percutaneous mitral valve intervention.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College Hospital NHS Trust: collaborator
• Manchester Metropolitan University: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE17EH, United Kingdom

Location

Related Publications (8)

• Attizzani GF, Fares A, Tam CC, Padaliya B, Mazzurco S, Popovich KL, Davis AC, Staunton E, Bezerra HG, Markowitz A, Simon DI, Costa MA, Sareyyupoglu B. Transapical Mitral Valve Implantation for the Treatment of Severe Native Mitral Valve Stenosis in a Prohibitive Surgical Risk Patient: Importance of Comprehensive Cardiac Computed Tomography Procedural Planning. JACC Cardiovasc Interv. 2015 Sep;8(11):1522-1525. doi: 10.1016/j.jcin.2015.04.025. Epub 2015 Aug 19. No abstract available.

  PMID: 26298225 BACKGROUND

• Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.

  PMID: 18848134 BACKGROUND

• De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.

  PMID: 24944303 BACKGROUND

• Kelley C, Lazkani M, Farah J, Pershad A. Percutaneous mitral valve repair: A new treatment for mitral regurgitation. Indian Heart J. 2016 May-Jun;68(3):399-404. doi: 10.1016/j.ihj.2015.08.025. Epub 2016 Jan 12.

  PMID: 27316505 BACKGROUND

• Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L; EVEREST II Investigators. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.

  PMID: 26718672 BACKGROUND

• Pedrazzini GB, Faletra F, Vassalli G, Demertzis S, Moccetti T. Mitral regurgitation. Swiss Med Wkly. 2010 Jan 23;140(3-4):36-43. doi: 10.4414/smw.2010.12893.

  PMID: 19950042 BACKGROUND

• Poulin F, Carasso S, Horlick EM, Rakowski H, Lim KD, Finn H, Feindel CM, Greutmann M, Osten MD, Cusimano RJ, Woo A. Recovery of left ventricular mechanics after transcatheter aortic valve implantation: effects of baseline ventricular function and postprocedural aortic regurgitation. J Am Soc Echocardiogr. 2014 Nov;27(11):1133-42. doi: 10.1016/j.echo.2014.07.001. Epub 2014 Aug 7.

  PMID: 25125314 BACKGROUND

• Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.

  PMID: 22922698 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A blood test will be performed as per routine clinical practice less than 3 months prior to cardiac intervention. Additionally a post procedure follow up blood test will be performed (approximately 3-6 months). Aside from routine blood tests, a small volume of additional blood will be obtained and analysed to test for Troponin T, ST2 and Galectin-3. On completion of testing, blood sample will be destroyed.

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Bernard Prendergast, B Med Sc DM

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 7, 2019
• Study Start: March 20, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)