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RF Ablation of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RF catheter ablation
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who are between 18 & 85 years of age. 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. Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen. 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: Any previous ablation of the left atrium (surgical or catheter based). Permanent or persistent atrial fibrillation. Recent myocardial infarction within 2 months Currently unstable angina. Any cardiac surgery during the previous 3 months. Currently documented intracardiac thrombus by transesophageal echocardiography (TEE). A left atrium > 50mm in major dimension. A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis. Permanent leads in or through the right atrium. Clinically significant valvular heart disease or a replacement heart valve. Congestive heart failure (NYHA classification III or IV). An ejection fraction <35%. A contraindication to warfarin. A contraindication to transseptal procedure. Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months. Any known bleeding disorder. Women who are known to be pregnant or nursing. Uncontrolled hyperthyroidism. Patients currently enrolled in any other clinical investigation. Any other significant uncontrolled or unstable medical condition. A life expectancy of less than one year. Currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.

Sites / Locations

  • David Haines, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

RF ablation

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2005
Last Updated
June 18, 2013
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT00265629
Brief Title
RF Ablation of Atrial Fibrillation
Official Title
A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the High Density Mesh Bard Ablation System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
RF ablation
Intervention Type
Device
Intervention Name(s)
RF catheter ablation
Intervention Description
RF ablation using mesh device
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are between 18 & 85 years of age. 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. Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen. 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: Any previous ablation of the left atrium (surgical or catheter based). Permanent or persistent atrial fibrillation. Recent myocardial infarction within 2 months Currently unstable angina. Any cardiac surgery during the previous 3 months. Currently documented intracardiac thrombus by transesophageal echocardiography (TEE). A left atrium > 50mm in major dimension. A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis. Permanent leads in or through the right atrium. Clinically significant valvular heart disease or a replacement heart valve. Congestive heart failure (NYHA classification III or IV). An ejection fraction <35%. A contraindication to warfarin. A contraindication to transseptal procedure. Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months. Any known bleeding disorder. Women who are known to be pregnant or nursing. Uncontrolled hyperthyroidism. Patients currently enrolled in any other clinical investigation. Any other significant uncontrolled or unstable medical condition. A life expectancy of less than one year. Currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.
Facility Information:
Facility Name
David Haines, MD
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

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RF Ablation of Atrial Fibrillation

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