Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry

In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Mitral Insufficiency; Mitral Stenosis; Mitral Stenosis With Insufficiency; Bioprosthesis Failure
• Intervention / Treatment: Procedure: Transcatheter mitral valve-in-valve implantation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Recruiting
    • Medical University of Białystok
    • Contact: Paweł Kralisz, MD, PhD; Phone Number: +48 85 746 84 96; Email: kki@umb.edu.pl
  • Gdańsk, Poland, 80-210
    • Recruiting
    • Medical University of Gdansk
    • Contact: Dariusz Jagielak, MD, PhD; Phone Number: +48 58 584 42 00; Email: kardchir@gumed.edu.pl
  • Katowice, Poland, 40-055
    • Recruiting
    • Medical University of Silesia
    • Contact: Wojciech Wojakowski, MD,PhD; Phone Number: +48 32 359 86 90; Email: kk3@gcm.pl
  • Opole, Poland, 45-052
    • Recruiting
    • Medical University of Opole
    • Contact: Jerzy Sacha, MD, PhD; Phone Number: +48 77 45 20 660; Email: kardiologia@usk.opole.pl
  • Warsaw, Poland, 02-091
    • Recruiting
    • Medical University of Warsaw
    • Contact: Maciej Mazurek, MD; Phone Number: +48 510265843; Email: maciej.j.mazurek@gmail.com
    • Principal Investigator: Zenon Huczek, MD, PhD
    • Sub-Investigator: Maciej Mazurek, MD
    • Sub-Investigator: Kajetan Grodecki, MD, PhD
  • Warsaw, Poland, 04-628
    • Recruiting
    • Institute of Cardiology
    • Contact: Adam Witkowski, MD, PhD; Phone Number: +48 22 343 43 42; Email: kchw@ikard.pl
    • Contact: Marcin Demkow, MD, PhD
  • Łódź, Poland, 90-419
    • Recruiting
    • Medical University of Łódź
    • Contact: Andrzej Walczak, MD, PhD; Phone Number: +48 42 201 44 60; Email: poczta@csk.umed.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Polish patients with failed surgically implanted mitral bioprosthetic valves, qualified by decision of the Heart Team to TMVR. All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.

Description

Inclusion Criteria:

• Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Qualification for TMVR by decision of the local Heart Team
• Patient provided written informed consent

Exclusion Criteria:

- Disqualification from TMVR

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause mortality	Endpoint described as n=x (y%).	1 year
Rate of hospitalization	Hospitalization for valve-related symptoms or worsening congestive heart failure. Endpoint described as n=x (y%).	1 year
Rate of neurological events	All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).	1 year
Rate of myocardial infarction	Endpoint described as n=x (y%).	1 year
Rate of valve-related dysfunction	Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value). Endpoint described as n=x (y%).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of technical success	Absence of procedural mortality; successful access, delivery, and retrieval of the device delivery system; successful deployment and correct positioning of the first intended device; freedom from emergency surgery or reintervention related to the device or access procedure. Endpoint described as n=x (y%).	at 24 hours
Rate of device success	Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical or interventional procedures related to the device or access procedure; continued intended safety and performance of the device. Endpoint described as n=x (y%).	30 days, 6 month, 1 year
Rate of procedural success	Device success (either optimal or acceptable), and absence of major device or procedure related serious adverse events, including: A. Death B. Stroke C. Life-threatening bleeding (Mitral Valve Academic Research Consortium scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥48 h. I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention Endpoint described as n=x (y%).	30 days
Rate of patient success	I. Device success; II. Patient returned to the pre-procedural setting; III. No rehospitalizations or reinterventions for the underlying condition; IV. Improvement from baseline in symptoms; improvement by ≥1 functional class in New York Heart Association scale. Nominal values from I to IV, where higher value indicates worse outcome; V. Improvement from baseline in functional status; improvement by ≥50 m in 6-min walk test. Continuous values in meters, where higher value indicates better outcome; VI. Improvement from baseline in quality-of-life; improvement by ≥10 in Kansas City Cardiomyopathy Questionnaire. Scores are scaled from 0 to 100, where higher value indicates better outcome. Endpoint described as n=x (y%).	1 year

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Institute of Cardiology, Warsaw, Poland; Medical University of Lodz; Medical University of Silesia; Medical University of Gdansk; Medical University of Bialystok; University of Opole

Publications and helpful links

General Publications

• Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Mitral regurgitation; Mitral valve insufficiency; Mitral stenosis; Transcatheter mitral valve replacement; Transcatheter mitral valve implantation; Mitral valve-in-valve; Bioprosthesis failure; Left ventricle outflow tract obstruction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Mitral Valve Insufficiency; Constriction, Pathologic; Mitral Valve Stenosis
• Other Study ID Numbers: WUM-MViV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes