Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation (CAMERA-Pilot)

April 26, 2023 updated by: Prof. Dr. Karl-Heinz Kuck (MD), University of Luebeck

Catheter Ablation or Percutaneous Mitral Valve Repair to Treat Essential (Moderate/Severe) Functional Mitral Regurgitation in Patients With Atrial Fibrillation - a Pilot Trial

The objective of the CAMERA-Pilot trial is to generate a hypothesis for a proper randomized controlled clinical endpoint trial to show the noninferiority of restoration and maintenance of sinus rhythm (via catheter ablation [CA] of AF) vs. mitral transcatheter edge-to-edge repair (M-TEER) in patients with AF and concomitant FMR. Patients will be stratified into ventricular FMR with atrial component and atrial FMR.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rhythm Control by Catheter Ablation: Patients randomized to rhythm control with CA will undergo CA of AF. The index procedure will comprise pulmonary vein isolation (PVI) using either the cryoballoon or radiofrequency (RF) current or pulsed field ablation at the discretion of the investigator. Additional atrial substrate modification may be performed at the discretion of the investigator.

The objective of rhythm control is to restore sinus rhythm by CA and to maintain sinus rhythm during the 12-month follow-up period. In case of AF recurrence during follow-up, sinus rhythm must be restored as soon as possible, either by adding or changing AADs, electrical cardioversion, or repeat CA.

No attempt will be made to reduce FMR by interventional means. Medical treatment of FMR will follow current guidelines.

M-TEER (Control): Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. The intervention will be considered successful if FMR is graded 2+ (moderate) or less by an echocardiography core laboratory in accordance with the 2017 Guidelines of the American Society of Echocardiography and specific guidelines on valvular regurgitation after percutaneous valve repair or replacement.

No attempt will be made to restore sinus rhythm, except for patients who remain symptomatic due to AF during follow-up. Medical treatment of AF will follow current guidelines.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic ventricular FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to cardiomyopathy of either ischemic or non-ischemic etiology (LVEF 30-49%), concomitant with AF
  • Symptomatic atrial FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to AF, with normal (≥50%) LVEF
  • LV end-systolic diameter ≤70 mm
  • Documented history of paroxysmal AF (PAF) or persistent AF for maximally 2 years
  • Subject has been adequately treated medically for at least 4 weeks per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation and heart failure
  • NYHA functional class II, III or ambulatory IV
  • Local heart team has determined that MV surgery is not indicated as a treatment option or will be high risk
  • Age 18-80 years

Exclusion Criteria:

  • Untreated clinically significant coronary artery disease requiring revascularization
  • CABG, PCI or TAVR within prior 30 days
  • Aortic or tricuspid valve disease (tricuspid regurgitation ≥3+) requiring surgery or transcatheter intervention
  • Cerebrovascular accident within prior 30 days
  • Severe symptomatic carotid stenosis (>70% by ultrasound)
  • Carotid surgery or stenting within prior 30 days
  • NYHA functional class IV requiring in-hospital care
  • Implant of CRT or CRT-D within the last 30 days
  • Transseptal puncture anatomically not feasible
  • Leaflet anatomy which may preclude MitraClip/PASCAL implantation, proper MitraClip/PASCAL positioning on the leaflets, or sufficient reduction in mitral regurgitation by the MitraClip/PASCAL device.
  • Current pregnancy or planned pregnancy within next 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhythm Control by Catheter Ablation:
Patients randomized to rhythm control with CA will undergo CA of AF.
Other: Catheter Ablation and M-TEER
Already included in arm descriptions.
Active Comparator: M-TEER (Control):
Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity.
Other: Catheter Ablation and M-TEER
Already included in arm descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMR grade ≤2+ (moderate or less) at 1 year
Time Frame: 24 Month
The FMR grade will be assessed with transesophageal echocardiography
24 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

February 28, 2025

Study Completion (Anticipated)

February 20, 2026

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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