Suspended
MITAVITreatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
What is being tested
Mitral Valve Clipping
+ TAVI
Device
Who is being recruted
Aortic Valve Disease+9
+ Aortic Diseases
+ Aortic Valve Stenosis
From 18 to 89 Years
+30 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: December 2019
Summary
Principal SponsorTechnische Universität Dresden
Study ContactAxel Linke, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2019
Actual date on which the first participant was enrolled.To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
Official TitleTreatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
Principal SponsorTechnische Universität Dresden
Study ContactAxel Linke, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1162 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 89 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Aortic Valve DiseaseAortic DiseasesAortic Valve StenosisCardiovascular DiseasesDiseaseHeart DiseasesHeart Valve DiseasesMitral Valve InsufficiencyPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesVentricular Outflow Obstruction
Criteria
6 inclusion criteria required to participate
Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
Moderate to severe mitral regurgitation
Symptom status NYHA II-III
Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
Show More Criteria
24 exclusion criteria prevent from participating
MR mechanism/anatomy precluding MitraClip therapy
Groin blood vessels are not eligible for TAVI procedure
Massive or torrential tricuspid regurgitation
Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTransfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
Group II
Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center