RF Ablation of Atrial Fibrillation
June 18, 2013 updated by: C. R. Bard
A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the High Density Mesh Bard Ablation System
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- David Haines, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
RF ablation
|
RF ablation using mesh device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 months
|
|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
December 14, 2005
First Submitted That Met QC Criteria
December 14, 2005
First Posted (ESTIMATE)
December 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEP-4405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.