Atrial Fibrillation Clinical Trial
Official title:
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
The AFIRE Trial is a prospective, multi-center clinical trial. The centers will utilize pre-screening of existing medical records to identify potentially eligible subjects. Once informed consent has been obtained, the subject will undergo baseline assessments, which include: Transthoracic echocardiography, transesophageal echocardiography, and functional assessments (Six-Minute Walk Test, NYHA, and Quality of Life Questionnaires). Following final eligibility determination, eligible subjects will under the index procedure to implant the Carillon device (includes coronary sinus venogram). Subject will be discharged following one-night in-hospital stay and discharge assessments. Subjects who have the Carillon implant procedure attempted but were not successfully implanted (Non-Implanted subjects) will be followed through discharge or resolution of safety events, whichever is longer, and then discharged from the trial. Implanted subjects will have follow-up assessments performed at 1 month, 6 months, and 12 months post index procedure. Follow-up assessments will include transthoracic echocardiography, Six-Minute Walk Test, and Quality of Life Questionnaires. ;
| 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 |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
| Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
| 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 |