Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)|
- Primary Efficacy Endpoint [ Time Frame: The primary efficacy endpoint will be assessed following the blanking interval through Month 12. ] [ Designated as safety issue: No ]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 [ Time Frame: The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later. ] [ Designated as safety issue: Yes ]
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 Efficacy Endpoint [ Time Frame: The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit. ] [ Designated as safety issue: No ]
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 [ Time Frame: The secondary safety endpoints will be assessed up to 3 years post procedure. ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: The Estech COBRA® Surgical System||
Device: The 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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683045
|United States, Arizona|
|Banner Good Samaritan Medical Center|
|Mesa, Arizona, United States, 85206|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|United States, Georgia|
|Saint Joseph's Hospital of Atlanta|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|North Shore Univ. Health System|
|Evanston, Illinois, United States, 60201|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|United States, Kansas|
|The Univ. of Kansas Hospital|
|Kansas City, Kansas, United States, 66160|
|United States, Michigan|
|Univ. of Michigan Cardiovascular Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Mayo Clinic / St. Mary's Hospital|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Lenox Hill Hospital / North Shore-LIJ Health System|
|New York, New York, United States, 10075|
|Mohawk Valley Heart Institute / St. Elizabeth Medical Center|
|Utica, New York, United States, 13501|
|United States, South Carolina|
|Sisters of Charity, Providence Hospital|
|Columbia, South Carolina, United States, 29204|
|United States, Virginia|
|Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery|
|Falls Church, Virginia, United States, 22041|
|United States, Wisconsin|
|Aurora St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53215|
|Principal Investigator:||David K Swanson, Ph.D.||Endoscopic Technologies, Inc|