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

This study is currently recruiting participants.
Verified February 2013 by Endoscopic Technologies, Inc
Sponsor:
Information provided by (Responsible Party):
Endoscopic Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01683045
First received: September 7, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Persistent Atrial Fibrillation
Device: The Estech COBRA® Surgical System

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Endoscopic Technologies, Inc:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 144
Study Start Date: September 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Estech COBRA Cooled™ Surgical Probe
  • Estech COBRA Adhere™ XL Surgical System
  • Estech COBRA Adhere™ XL 2 Surgical System
  • Estech COBRA® Revolution Bipolar Clamp

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

  1. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

    1. Mitral valve repair or replacement,
    2. Aortic valve repair or replacement,
    3. Tricuspid valve repair or replacement, or
    4. Coronary Artery Bypass procedures;
  2. 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;
  3. Age 18 to 80 years old;
  4. Left ventricular ejection fraction (LVEF) ≥ 30%;
  5. Subject has no contraindications to intraoperative transesophageal echocardiography;
  6. Subject has a life expectancy greater than 12 months; and
  7. 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.

Exclusion Criteria:

Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:

  1. History of non-paroxysmal AF less than 3 months or for more than 5 years;
  2. History of prior cardiac ablative surgical or catheter-based therapy;
  3. Previous cardiac surgery (redo) or other intrapericardial procedures;
  4. Class IV NYHA heart failure;
  5. Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
  6. Wolff-Parkinson-White syndrome;
  7. Need for emergent cardiac surgery (e.g., cardiogenic shock);
  8. Untreated hyperthyroidism;
  9. Untreated hypothyroidism;
  10. Acute pulmonary disease;
  11. Electrolyte imbalance;
  12. History of myocarditis;
  13. 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);
  14. History of pericarditis;
  15. Previous left phrenic nerve paralysis;
  16. Bullous lung disease;
  17. Presence of active endocarditis, or local or systemic infection;
  18. Recent myocardial infarction (< 3 months);
  19. Renal failure requiring dialysis or hepatic failure or creatinine of >2 mg/dL preoperatively;
  20. Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
  21. Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
  22. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
  23. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
  24. Documented left atrial size of 6 cm or more;
  25. History of cerebrovascular disease or accident, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment;
  26. Known contraindication to anticoagulant therapy or inability to comply with anticoagulant therapy;
  27. Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
  28. Forced expiratory volume in 1 second less than 30% of predicted value or need for home oxygen therapy; or
  29. Surgical management of hypertrophic obstructive cardiomyopathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683045

Locations
United States, Arizona
Banner Good Samaritan Medical Center Not yet recruiting
Mesa, Arizona, United States, 85206
Contact: Barbara Lambeth, RN, CCRC, CCRP    480-854-5178    barbara.lambeth@bannerhealth.org   
Principal Investigator: Kenith Fang, MD         
United States, Connecticut
Hartford Hospital Not yet recruiting
Hartford, Connecticut, United States, 06102
Contact: Maureen Yuscavich       Myuscavitch@harthosp.org   
Contact: Lizabeth Roper, MHS    860-545-1964    lroper@harthosp.org   
Principal Investigator: Bob Hagberg, M.D.         
United States, Georgia
Saint Joseph's Hospital of Atlanta / Emory Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact: Sonya Mathewson, R.N., B.S.N., C.C.R.C.    678-843-6092    Sonya.Mathewson@emoryhealthcare.org   
Principal Investigator: Charles A. Anderson, M.D.         
United States, Illinois
North Shore Univ. Health System Not yet recruiting
Evanston, Illinois, United States, 60201
Contact: Agnes K. Brugger, R.N.    847-570-1871    kbrugger@northshore.org   
Principal Investigator: Paul Pearson, M.D.         
Advocate Christ Medical Center Not yet recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Colleen Gallagher, B.S.N.    708-346-4040 ext 133    colleen.gallagher@advocatehealth.com   
Contact: Mary J Borg, RN, BSN    798-346-4044 ext 134    mborg@ctvsurgeons.com   
Principal Investigator: Antone Tatooles, M.D.         
United States, Kansas
The Univ. of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donita Atkins, RN, BSN, CCRC    913-588-9714    datkins2@kumc.edu   
Contact: Caroline Murray, RN    913-588-9679    cmurray@mac.md   
Principal Investigator: Emmanuel Daon, M.D.         
Sub-Investigator: Trip Zorn, MD         
United States, Michigan
Univ. of Michigan Cardiovascular Center Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cathie Bloem, M.P.H., R.N.    734-615-6170    bloem@med.umich.edu   
Principal Investigator: Steven Bolling, M.D.         
United States, Minnesota
Mayo Clinic / St. Mary's Hospital Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: June Kendall-Thomas, R.N., B.S.N.    507-255-2673    KendallThomas.June15@mayo.edu   
Principal Investigator: Lyle Joyce, M.D.         
United States, New York
Lenox Hill Hospital / North Shore-LIJ Health System Not yet recruiting
New York, New York, United States, 10075
Contact: Joan Jennings, R.N., M.A.    212-434-2851    JJennings1@NSHS.edu   
Principal Investigator: Nirav C. Patel, M.D.         
Mohawk Valley Heart Institute / St. Elizabeth Medical Center Recruiting
Utica, New York, United States, 13501
Contact: Michael R. Passacantando, R.N.    315-235-7476    mpassacantando@stemc.org   
Principal Investigator: Frederic Joyce, M.D.         
United States, South Carolina
Sisters of Charity, Providence Hospital Recruiting
Columbia, South Carolina, United States, 29204
Contact: Jacqueline Sheriod-Scott, R.N.    803-255-2927      
Principal Investigator: John P. Sutton, M.D.         
United States, Virginia
Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery Recruiting
Falls Church, Virginia, United States, 22041
Contact: Casey Miller    703-776-7137    casey.miller@inova.org   
Principal Investigator: Niv Ad, M.D.         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Jennifer A. Cooper, R.N., C.C.R.C.    414-385-2504    jennifer.cooper@aurora.org   
Principal Investigator: David Kress, M.D.         
Sponsors and Collaborators
Endoscopic Technologies, Inc
Investigators
Principal Investigator: David K Swanson, Ph.D. Endoscopic Technologies, Inc
  More Information

No publications provided

Responsible Party: Endoscopic Technologies, Inc
ClinicalTrials.gov Identifier: NCT01683045     History of Changes
Other Study ID Numbers: 400-02, ATTAC-AF
Study First Received: September 7, 2012
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endoscopic Technologies, Inc:
non-paroxysmal atrial fibrillation
persistent atrial fibrillation
atrial fibrillation
heart palpitations
irregular heart beat
temperature-controlled radiofrequency ablation
radiofrequency energy
TCRF energy
RF energy
epicardial and endocardial lesions
concomitant heart surgery
surgical ablation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014