Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00785902
NCT00785902WithdrawnPhase 3

AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

AtriCure, Inc.0 sitesStarted: November 5, 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Primary Endpoint
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.
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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
  • •Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
  • •Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Outcomes

Primary Outcomes

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

  • 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.

Investigators

Sponsor Class
Industry

Similar Trials

Completed
Phase 3
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial FibrillationAtrial Fibrillation
NCT00560885AtriCure, Inc.55
Completed
Not Applicable
Bipolar Ventricular Tachycardia (VT) StudyVentricular Tachycardia
NCT02374476Srinivas Dukkipati145
Completed
Not Applicable
LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial FibrillationLong-standing Persistent AF
NCT06128174Vivek Reddy20
Completed
Not Applicable
Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular TechniqueHepatocellular Carcinomas
NCT01008657Assistance Publique - Hôpitaux de Paris216
Recruiting
Not Applicable
Driver-guided Ablation of Persistent Atrial FibrillatiomPersistent Atrial Fibrillation
NCT04085731IRCCS Policlinico S. Donato181