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

Persistent Atrial Fibrillation Clinical Trial

Official title:

Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01683045
• Other study ID #: 400-02
• Secondary ID: ATTAC-AF
• Status: Terminated
• Phase: N/A
• First received: September 7, 2012
• Last updated: April 22, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2014
• Source: Endoscopic Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Univ. of Michigan Cardiovascular Center	Ann Arbor	Michigan
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Sisters of Charity, Providence Hospital	Columbia	South Carolina
United States	North Shore Univ. Health System	Evanston	Illinois
United States	Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery	Falls Church	Virginia
United States	Hartford Hospital	Hartford	Connecticut
United States	The Univ. of Kansas Hospital	Kansas City	Kansas
United States	Banner Good Samaritan Medical Center	Mesa	Arizona
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Lenox Hill Hospital / North Shore-LIJ Health System	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Mayo Clinic / St. Mary's Hospital	Rochester	Minnesota
United States	Mohawk Valley Heart Institute / St. Elizabeth Medical Center	Utica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Endoscopic Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	Yes
Secondary	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.	The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.	No
Secondary	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.	The secondary safety endpoints will be assessed up to 3 years post procedure.	Yes