Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05332782

Acronym

PRIME-MR

Enrollment

2000

Registered

2022-04-18

Start date

2022-03-01

Completion date

2026-01-01

Last updated

2022-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Brief summary

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* clinically significant primary mitral regurgitation * patient underwent M-TEER * echocardiography data at baseline, procedure and follow-up * follow-up of at least 12 months

Exclusion criteria

* age under 18 years

Design outcomes

Primary

Measure	Time frame	Description
All-cause mortality	12 months	Incidence of death from any cause.
Cardiovascular mortality	12 months	Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Rehospitalization for congestive heart failure	12 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Re-do mitral valve procedure	12 months	Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.

Secondary

Measure	Time frame	Description
MVARC (Mitral Valve Academic Research Consortium) Technical success	1 day (at exit from the catheterization laboratory)	All of the following must be present: 1. Absence of procedural mortality 2. Successful access, delivery, and retrieval 3. Successful deployment and correct positioning of the first device 4. Freedom from emergency surgery or reintervention related to the device or access procedure
Functional success	1 day (at exit from the catheterization laboratory)	If one of the following is present: 1. Residual mitral regurgitation ≤2+ 2. Effective regurgitant orifice area ≤15 mm2 3. Transmitral gradient \<5 mmHg
Residual mitral regurgitation	up to 30 days	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge.

Countries

France, Germany, United States

Contacts

Primary ContactBenedikt Koell, MD

b.koell@uke.de+4915222815230

Backup ContactSebastian Ludwig, MD

se.ludwig@uke.de+491522816168

Outcome results