RF Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the High Density Mesh Bard Ablation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265629
• Other study ID #: BEP-4405
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2005
• Last updated: June 18, 2013
• Start date: August 2005
• Est. completion date: October 2009

Study information

• Verified date: June 2013
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• RF catheter ablation
RF ablation using mesh device

Locations

Country	Name	City	State
United States	David Haines, MD	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	Yes
Primary	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.		12 months	No