Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats

Stopped early · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01683045

Run by

Endoscopic Technologies, Inc

People needed

6

Starts

2012-09-01

Expected to finish

2014-05-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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…

• Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:
• 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;
• Bullous lung disease;
• Presence of active endocarditis, or local or systemic infection;
• Recent myocardial infarction (< 3 months);
• Renal failure requiring dialysis or hepatic failure or creatinine of >2 mg/dL preoperatively;
• Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
• Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
• Documented left atrial size of 6 cm or more;

Where it is running

• Banner Good Samaritan Medical Center — Mesa, Arizona, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Saint Joseph's Hospital of Atlanta — 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
• Sisters of Charity, Providence Hospital — Columbia, South Carolina, United States
• Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery — Falls Church, Virginia, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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