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Study 2 of 3 for search of: | "Ablation Frontiers" [Exact] |
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Ablation Frontiers |
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Information provided by: | Ablation Frontiers |
ClinicalTrials.gov Identifier: | NCT00744835 |
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 |
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 |
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
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Procedure: Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Jerald L Cox, PA | Ablation Frontiers, Inc. |
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 |
atrial fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |