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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Banner Good Samaritan Medical Center
Mesa, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Saint Joseph's Hospital of Atlanta
Primary Efficacy Endpoint
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.
Time frame: The primary efficacy endpoint will be assessed following the blanking interval through Month 12.
Primary Safety Endpoint
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.
Time frame: The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.
Secondary Efficacy Endpoint
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.
Time frame: The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.
Secondary Safety Endpoint
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atlanta, Georgia, United States
North Shore Univ. Health System
Evanston, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
The Univ. of Kansas Hospital
Kansas City, Kansas, United States
Univ. of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Mayo Clinic / St. Mary's Hospital
Rochester, Minnesota, United States
Lenox Hill Hospital / North Shore-LIJ Health System
New York, New York, United States
Mohawk Valley Heart Institute / St. Elizabeth Medical Center
Utica, New York, United States
...and 3 more locations
Time frame: The secondary safety endpoints will be assessed up to 3 years post procedure.