AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

NCT00785902 | Withdrawn Phase 3 DMC

• 1 other identifier: CP2008-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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.

• The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge

Secondary Outcomes (2)

• The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months

• The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.

Interventions

AtriCure Bipolar System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is greater than or equal to 18 years of age
• Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
• 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
• Subject's Left Ventricular Ejection Fraction ≥ 30%
• Subject is able and willing to provide written informed consent and comply with study requirements
• Subject has life expectancy of at least 1 year

You may not qualify if:

• Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
• Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
• Wolff-Parkinson-White syndrome
• Prior cardiac surgery (Redo)
• Class IV NYHA heart failure symptoms
• Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
• Documented MI within 6 weeks prior to study enrollment
• Need for emergent cardiac surgery (i.e. cardiogenic shock)
• Known carotid artery stenosis greater than 80%
• LA size greater than or equal to 8 cm
• Current diagnosis of active systemic infection
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
• Pregnancy or desire to get pregnant within 12-months of the study enrollment
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes
• Renal failure requiring dialysis or hepatic failure

Sponsors & Collaborators

• AtriCure, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Last Updated: February 21, 2011

Record last verified: 2011-02