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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00469638 |
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.
Condition | Intervention |
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Atrial Fibrillation |
Procedure: left atrial catheter ablation guided by introducer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0. |
Estimated Enrollment: | 130 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2008 |
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.
Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerhard Hindricks, Prof. Dr. | +49 341 865 1421 |
Germany | |
Herzzenturm Leipzig | Recruiting |
Leipzig, Germany, 04289 | |
Principal Investigator: Gerhard Hindricks, Prof. Dr. |
Principal Investigator: | Gerhard Hindricks, Prof. Dr. | Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany |
Study ID Numbers: | A07 |
Study First Received: | May 3, 2007 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00469638 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
atrial fibrillation paroxysmal persistent symptomatic ablation catheter |
introducer Agilis NxT sinus rhythm paroxysmal atrial fibrillation persistent atrial fibrillation symptomatic atrial fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |