RF Ablation of Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265629
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:

This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation.

This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: RF catheter ablation Phase 1

Detailed Description:
This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the High Density Mesh Bard Ablation System
Study Start Date : August 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
RF ablation
Device: RF catheter ablation
RF ablation using mesh device

Primary Outcome Measures :
  1. Evaluate the safety of the HDMA when used to map & ablate patients with AF, by assessing MCs at 7-days & 30 days post-procedure & assessing the occurrence of pulmonary vein stenosis at 3 & 12 months post-procedure. [ Time Frame: 12 months ]
  2. Evaluate the preliminary effectiveness of the HDMA when used to map and ablate patients with paroxysmal AF, by assessing APS & the freedom from recurrence of symptomatic AF at 3, 6 & 12 months post- procedure. [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who are between 18 & 85 years of age.
  2. Patients with a minimum of 2 episodes of symptomatic PAF within the last 6 months prior to baseline evaluation. At least one of these episodes must have been documented. Documentation may include electrocardiogram (ECG), trans telephonic monitoring (TTM), Holter monitoring (HM), or telemetry strip. Additional PAF episodes (i.e., verbal accounts from the patient) will be documented in the patient's study record.
  3. Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen.
  4. Patients with the ability to understand the requirements of the study, who have provided written informed consent and agreed to the study restrictions and to return for the required follow-up assessments.

Exclusion Criteria:

  1. Any previous ablation of the left atrium (surgical or catheter based).
  2. Permanent or persistent atrial fibrillation.
  3. Recent myocardial infarction within 2 months
  4. Currently unstable angina.
  5. Any cardiac surgery during the previous 3 months.
  6. Currently documented intracardiac thrombus by transesophageal echocardiography (TEE).
  7. A left atrium > 50mm in major dimension.
  8. A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis.
  9. Permanent leads in or through the right atrium.
  10. Clinically significant valvular heart disease or a replacement heart valve.
  11. Congestive heart failure (NYHA classification III or IV).
  12. An ejection fraction <35%.
  13. A contraindication to warfarin.
  14. A contraindication to transseptal procedure.
  15. Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months.
  16. Any known bleeding disorder.
  17. Women who are known to be pregnant or nursing.
  18. Uncontrolled hyperthyroidism.
  19. Patients currently enrolled in any other clinical investigation.
  20. Any other significant uncontrolled or unstable medical condition.
  21. A life expectancy of less than one year.
  22. Currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265629

United States, Michigan
David Haines, MD
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
C. R. Bard

Responsible Party: C. R. Bard Identifier: NCT00265629     History of Changes
Other Study ID Numbers: BEP-4405
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by C. R. Bard:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes