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

Recruiting

• Conditions: Mitral Insufficiency; Mitral Stenosis With Insufficiency; Heart Failure; Mitral Stenosis; Bioprosthesis Failure

• Registration Number: NCT05625607
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of myocardial infarction	1 year	Endpoint described as n=x (y%).
Rate of all-cause mortality	1 year	Endpoint described as n=x (y%).
Rate of hospitalization	1 year	Hospitalization for valve-related symptoms or worsening congestive heart failure.; Endpoint described as n=x (y%).
Rate of neurological events	1 year	All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).
Rate of valve-related dysfunction	1 year	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%).

Secondary Outcome Measures

Name	Time	Method
Rate of procedural success	30 days	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%).
Rate of technical success	at 24 hours	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%).
Rate of device success	30 days, 6 month, 1 year	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%).
Rate of patient success	1 year	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%).

Trial Locations

Locations (7)

Medical University of Silesia; 🇵🇱 Katowice, Poland

Institute of Cardiology; 🇵🇱 Warsaw, Poland

Medical University of Białystok; 🇵🇱 Białystok, Poland

Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland

Medical University of Opole; 🇵🇱 Opole, Poland

Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Medical University of Łódź; 🇵🇱 Łódź, Poland