Clinical trial NCT04818502: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Official title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mitral Valve Regurgitation
Keywords: Tendyne
Tendyne Mitral Valve System
Transcatheter
Mitral Regurgitation
Heart Valve disease
Mitral Valve Regurgitation
Mitral Insufficiency
Transcatheter intervention
Transcatheter Mitral Valve Implantation
Transcatheter Mitral Valve Replacement
Transapical Transcatheter Mitral Valve Implantation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.

Brief summary: To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Detailed description: The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.

The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.

Eligibility criteria: Inclusion Criteria:

1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
3. Patient provides written informed consent prior to any study-specific procedure.

Exclusion Criteria:

1. Patient is in another clinical study that may impact the follow-up or results of this study.
2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
3. Patient is under the age of 18 or age of legal consent.
4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.

Primary outcomes:
measure: Primary Endpoint for MR Elimination at 1 Year
timeFrame: At 1 year
Secondary outcomes:
measure: Procedure Safety (PS)
timeFrame: Day 0, at exit procedure room
measure: Freedom from LVOT Obstruction (LVOTO) at 30 Days
timeFrame: At Day 30
measure: Freedom from Paravalvular Leak (PVL) at 30 Days
timeFrame: At Day 30
measure: Left Ventricle Reverse Remodeling at 1 Year
timeFrame: At 1 Year
measure: All-Cause Mortality at 30 Days
timeFrame: At Day 30
measure: Long-term Device Durability (LDD) at 5 Years
timeFrame: At 5 Years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Praha
country: Czechia
facility: IKEM Prague
city: Třinec
country: Czechia
facility: Hospital AGEL Trinec-Podlesi
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Lyon University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
city: Berlin
country: Germany
facility: German Heart Center Berlin
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Köln
country: Germany
facility: Universitätsclinic Cologne
city: Leipzig
country: Germany
facility: Leipzig Heart Center
city: Mainz
country: Germany
facility: University Medical Center Mainz
city: Munich
country: Germany
facility: German Heart Center Munich
city: München
country: Germany
facility: Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern
city: Stuttgart
country: Germany
facility: Robert-Bosch Krankenhaus
city: Jerusalem
country: Israel
facility: Shaare Zedek Jerusalem
city: Tel Aviv
country: Israel
facility: Sheba Medical Centre
city: Ancona
country: Italy
facility: Lancisi Cardiovascular Center - Politechnic University of Marcher
city: Brescia
country: Italy
facility: AOU Civili Brescia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Maastricht
country: Netherlands
facility: MUMC+
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Madrid
country: Spain
facility: Clinico San Carlos
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic for Cardiac Surgery
city: Bern
country: Switzerland
facility: Insel Bern
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References: