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RF Ablation of Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00265629
First received: December 14, 2005
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Device: RF catheter ablation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2005
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RF ablation
 Device: RF catheter ablation
RF ablation using mesh device

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265629

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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00265629     History of Changes
Other Study ID Numbers: BEP-4405
Study First Received: December 14, 2005
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Atrial fibrillation

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

ClinicalTrials.gov processed this record on June 18, 2013