Atrial Fibrillation Ablation Pilot Study - Full Text View

Sponsored by:	Ablation Frontiers
Information provided by:	Ablation Frontiers
ClinicalTrials.gov Identifier:	NCT00744835

Purpose

This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: Ablation procedure and/or cardioversion	Phase I

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20

Further study details as provided by Ablation Frontiers:

Primary Outcome Measures:

The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	53
Study Start Date:	August 2006
Study Completion Date:	July 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ablation Management	Procedure: Ablation procedure and/or cardioversion Ablation Frontiers Cardiac Ablation System

Detailed Description:

The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.

Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of symptomatic permanent atrial fibrillation
Age between 18 and 70
Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion Criteria:

Structural heart disease of clinical significance
Any prior ablation for atrial fibrillation
Prior ablation for arrhythmias other than AF within the past three months
Enrollment in any other ongoing arrhythmia study protocol
Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
Active infection or sepsis
Any history of cerebral vascular disease including stroke or TIAs
Pregnancy or lactation
Left atrial thrombus at the time of ablation
Untreatable allergy to contrast media
Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
History of blood clotting (bleeding or thrombotic) abnormalities
Known sensitivities to heparin or warfarin
Severe COPD (identified by an FEV1 < 1)
Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744835

Locations

Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Switzerland
Klinic im Park
Zürich, Switzerland
United Kingdom
Papworth Hospital
Cambridge, United Kingdom
St. Mary's Hospital
London, United Kingdom
St. George's University of London
London, United Kingdom

Sponsors and Collaborators

Ablation Frontiers

Investigators

Study Director:

Jerald L Cox, PA

Ablation Frontiers, Inc.

More Information

Additional Information:

Company website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ablation Frontiers, Inc. ( Jerald Cox, Director of Clinical Affairs )
Study ID Numbers:	AFI-20
Study First Received:	August 28, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744835
Health Authority:	Switzerland: Swissmedic

Keywords provided by Ablation Frontiers:

atrial fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009