An interventional study of The Estech COBRA® Surgical System in Persistent Atrial Fibrillation, sponsored by Endoscopic Technologies, Inc. Terminated at 13 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-23.
Sponsored by Endoscopic Technologies, Inc · Not applicable, Interventional, and Treatment
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 6 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Endoscopic Technologies, Inc as lead sponsor.
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All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
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 exclusion criteria:
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.
Also known as: Estech COBRA Cooled™ Surgical Probe, Estech COBRA Adhere™ XL Surgical System, Estech COBRA Adhere™ XL 2 Surgical System, Estech COBRA® Revolution Bipolar Clamp
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.
Time frame: The secondary safety endpoints will be assessed up to 3 years post procedure.
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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