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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625607
• Other study ID #: WUM-MViV
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2022
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Heart Failure
• Mitral Insufficiency
• Mitral Stenosis
• Mitral Stenosis With Insufficiency
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Intervention

Procedure:
• Transcatheter mitral valve-in-valve implantation
Transcatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing.

Locations

Country	Name	City	State
Poland	Medical University of Bialystok	Bialystok
Poland	Medical University of Gdansk	Gdansk
Poland	Medical University of Silesia	Katowice
Poland	Medical University of Lódz	Lódz
Poland	Medical University of Opole	Opole
Poland	Institute of Cardiology	Warsaw
Poland	Medical University of Warsaw	Warsaw

Sponsors (7)

Lead Sponsor	Collaborator
Medical University of Warsaw	Institute of Cardiology, Warsaw, Poland, Medical University of Bialystok, Medical University of Gdansk, Medical University of Lodz, Medical University of Silesia, University of Opole

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality	Endpoint described as n=x (y%).	1 year
Primary	Rate of hospitalization	Hospitalization for valve-related symptoms or worsening congestive heart failure.; Endpoint described as n=x (y%).	1 year
Primary	Rate of neurological events	All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).	1 year
Primary	Rate of myocardial infarction	Endpoint described as n=x (y%).	1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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