Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats
Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)
2 other identifiers
interventional
6
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 23, 2014
April 1, 2014
1.3 years
September 7, 2012
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.
Secondary Outcomes (2)
Secondary Efficacy Endpoint
The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.
Secondary Safety Endpoint
The secondary safety endpoints will be assessed up to 3 years post procedure.
Study Arms (1)
The Estech COBRA® Surgical System
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- Mitral valve repair or replacement,
- Aortic valve repair or replacement,
- Tricuspid valve repair or replacement, or
- Coronary Artery Bypass procedures;
- 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;
- Age 18 to 80 years old;
- Left ventricular ejection fraction (LVEF) ≥ 30%;
- Subject has no contraindications to intraoperative transesophageal echocardiography;
- Subject has a life expectancy greater than 12 months; and
- 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.
You may not qualify if:
- History of non-paroxysmal AF less than 3 months or for more than 5 years;
- History of prior cardiac ablative surgical or catheter-based therapy;
- Previous cardiac surgery (redo) or other intrapericardial procedures;
- Class IV NYHA heart failure;
- Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
- Wolff-Parkinson-White syndrome;
- Need for emergent cardiac surgery (e.g., cardiogenic shock);
- Untreated hyperthyroidism;
- Untreated hypothyroidism;
- Acute pulmonary disease;
- Electrolyte imbalance;
- History of myocarditis;
- Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy (e.g., valvular prosthesis or ring, pacemaker with leads in coronary sinus or internal defibrillator leads);
- History of pericarditis;
- Previous left phrenic nerve paralysis;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Banner Good Samaritan Medical Center
Mesa, Arizona, 85206, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
North Shore Univ. Health System
Evanston, Illinois, 60201, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
The Univ. of Kansas Hospital
Kansas City, Kansas, 66160, United States
Univ. of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109, United States
Mayo Clinic / St. Mary's Hospital
Rochester, Minnesota, 55905, United States
Lenox Hill Hospital / North Shore-LIJ Health System
New York, New York, 10075, United States
Mohawk Valley Heart Institute / St. Elizabeth Medical Center
Utica, New York, 13501, United States
Sisters of Charity, Providence Hospital
Columbia, South Carolina, 29204, United States
Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery
Falls Church, Virginia, 22041, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David K Swanson, Ph.D.
Endoscopic Technologies, Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 11, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2014
Study Completion
May 1, 2014
Last Updated
April 23, 2014
Record last verified: 2014-04