Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05846412
Study type Interventional
Source University of Luebeck
Contact
Status Not yet recruiting
Phase N/A
Start date June 1, 2023
Completion date February 20, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A