NCT05846412

Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Atrial Fibrillation
• Mitral Regurgitation Functional

Interventions

Type	Name	Description
OTHER	Catheter Ablation and M-TEER	Already included in arm descriptions.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-02-28
• Completion: 2026-02-20
• First posted: 2023-05-06
• Last updated: 2023-05-06