CClinicalTrials.gg
WithdrawnNCT00785902AUpdated Feb 21, 2011

AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

A Phase 3 interventional study of AtriCure Bipolar System in Atrial Fibrillation, sponsored by AtriCure, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-21.

Sponsored by AtriCure, Inc. · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

Browse Atrial Fibrillation studies →

Lead sponsor

AtriCure, Inc. is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3

Interventions

  • DeviceAtriCure Bipolar System
06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

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

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00785902
Lead sponsor
AtriCure, Inc.
First posted
Nov 5, 2008
Last update
Feb 21, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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