Clinical trial NCT05625607: Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
Official title: Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Insufficiency
Mitral Stenosis
Mitral Stenosis With Insufficiency
Heart Failure
Bioprosthesis Failure
Keywords: Transcatheter mitral valve replacement
Transcatheter mitral valve implantation
Mitral valve-in-valve
Mitral valve insufficiency
Mitral stenosis
Mitral regurgitation
Bioprosthesis failure
Left ventricle outflow tract obstruction
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: National Institute of Cardiology, Warsaw, Poland
name: Medical University of Bialystok
name: University of Opole
name: Medical University of Gdansk
name: Medical University of Silesia
name: Medical University of Lodz
First posted: 2022-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of all-cause mortality
timeFrame: 1 year
measure: Rate of hospitalization
timeFrame: 1 year
measure: Rate of neurological events
timeFrame: 1 year
measure: Rate of myocardial infarction
timeFrame: 1 year
measure: Rate of valve-related dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: Rate of technical success
timeFrame: at 24 hours
measure: Rate of device success
timeFrame: 30 days, 6 month, 1 year
measure: Rate of procedural success
timeFrame: 30 days
measure: Rate of patient success
timeFrame: 1 year
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Białystok
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Opole
country: Poland
facility: Medical University of Opole
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Łódź
country: Poland
facility: Medical University of Łódź
Study officials:
References:
citation: 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.