Persistent Atrial Fibrillation
Conditions
Keywords
non-paroxysmal atrial fibrillation, persistent atrial fibrillation, atrial fibrillation, heart palpitations, irregular heart beat, temperature-controlled radiofrequency ablation, radiofrequency energy, TCRF energy, RF energy, epicardial and endocardial lesions, concomitant heart surgery, surgical ablation
Brief summary
The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an effective treatment for patients with irregular heart beats who are undergoing heart surgery.
Detailed description
The objective of the trial is to demonstrate that the creation of epicardial and endocardial lesions with temperature-controlled radiofrequency (TCRF) ablation applied using the Estech COBRA® Surgical System during concomitant heart surgery is a safe and effective treatment for non-paroxysmal atrial fibrillation (AF).
Interventions
DEVICEThe Estech COBRA® Surgical System
The Estech COBRA® Surgical System has been designed to create epicardial and endocardial lesions on the heart using temperature controlled radiofrequency (TCRF) ablation with the Estech COBRA surgical probes. Temperature control provides a meaningful endpoint, maintaining tissue at safe yet effective temperatures to produce the desired lesion set. Internal probe cooling and advanced suction helps to ensure reproducible transmural (full-thickness) endocardial or epicardial lesions.
Sponsors
Endoscopic Technologies, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial: 1. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: 1. Mitral valve repair or replacement, 2. Aortic valve repair or replacement, 3. Tricuspid valve repair or replacement, or 4. Coronary Artery Bypass procedures; 2. Subject has history of a non-paroxysmal form of AF for greater than 3 months and has failed at least one attempt at electrical cardioversion or had a successful attempt at electrical cardioversion but had a recurrence of AF within 30 days of the cardioversion; 3. Age 18 to 80 years old; 4. Left ventricular ejection fraction (LVEF) ≥ 30%; 5. Subject has no contraindications to intraoperative transesophageal echocardiography; 6. Subject has a life expectancy greater than 12 months; and 7. Willing and capable of providing Informed Consent to undergo surgery and participate in all examinations and follow-ups associated with this clinical trial. A subject is considered to have failed electrical cardioversion if they did not achieve sinus rhythm for at least 30 seconds following the attempted cardioversion.
Exclusion criteria
Subjects will be excluded from participating in this trial if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | The primary efficacy endpoint will be assessed following the blanking interval through Month 12. | Proportion of subjects that achieve procedural and therapeutic success. Procedural success is defined as the performance of the protocol specified lesions with the designated devices. Therapeutic success is defined as freedom from AF, AFL (atrial flutter) and AT (atrial tachycardia, not including sinus tachycardia) following the blanking interval through Month 12. |
| Primary Safety Endpoint | The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later. | A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following early onset (i.e., within 30 days of the TCRF ablation procedure or hospital discharge, whichever is later) serious adverse events (SAEs): * Cardiac death; * Stroke and transient ischemic attack (TIA); * Myocardial infarction (MI); * Excessive bleeding; or * Atrioesophageal fistula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint | The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit. | The secondary efficacy endpoints include: * Proportion of subjects that achieve bilateral pulmonary vein conduction block. * AF burden at 6 and 12 months based on the proportion of time a subject is in AF (% of 24 hours) from the 24-hour continuous ECG monitor. |
| Secondary Safety Endpoint | The secondary safety endpoints will be assessed up to 3 years post procedure. | The proportion of subjects with acute onset post-surgical symptomatic diaphragmatic paralysis that is still present at the Month 12 follow-up visit. The proportion of subjects reporting one or more SAEs for each follow-up interval. The intervals will include the period from: * the surgical procedure for the surgical TCRF ablation through the Day 30 follow-up visit; * the Day 30 follow-up visit through the Month 3 follow-up visit; * the Month 3 follow-up visit through the Month 6 follow-up visit; and * the Month 6 follow-up visit through the Month 12 follow-up visit. Additionally, the proportion of subjects reporting one or more SAEs annually for years 2 and 3 post procedure. |
Countries
United States
Outcome results
None listed