Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Cologne
About this trial
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
functional mitral regurgitation
left ventricular ejection fraction ≥50%
Disqualifiers
age under 18 years
known regional wall movement disorders
Trial population
This study aimes to include all patients with clinically significant mitral regurgitation of the atrial functional mitral regurgitation subtype, irrespective of the subsequent therapy.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 3 trial groupsGroup A: Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER)
Group B: Guideline Directed Medical Therapy
Group C: Transcatheter Mitral Valve Replacement (TMVR)
Trial outcomes
Primary outcomes
1
Composite of all-cause mortality and heart-failure related rehospitalitzation
Time frame
12 monthsSecondary outcomes
1
Residual Mitral Regurgitation ≤1+
Rate of patients achieving residual mitral regurgitation ≤1+ measured by transthoracic echocardiography. Assessment of mitral regurgitation severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Time frame
12 months2
All-cause mortality
Time frame
12 months3
Cardiovascular mortality
Time frame
12 months4
Heart failure related rehospitalization
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov