AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00785902
• Other study ID #: CP2008-1
• Status: Withdrawn
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: February 18, 2011

Study information

• Verified date: February 2011
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age

2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines

3. 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

• Coronary Artery Bypass procedures

4. Subject's Left Ventricular Ejection Fraction = 30%

5. Subject is able and willing to provide written informed consent and comply with study requirements

6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted

2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure

3. Wolff-Parkinson-White syndrome

4. Prior cardiac surgery (Redo)

5. Class IV NYHA heart failure symptoms

6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit

7. Documented MI within 6 weeks prior to study enrollment

8. Need for emergent cardiac surgery (i.e. cardiogenic shock)

9. Known carotid artery stenosis greater than 80%

10. LA size greater than or equal to 8 cm

11. Current diagnosis of active systemic infection

12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion

13. Pregnancy or desire to get pregnant within 12-months of the study enrollment

14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

15. Renal failure requiring dialysis or hepatic failure

16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Study Design

N/A

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AtriCure Bipolar System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
Primary	The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
Secondary	The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
Secondary	The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.