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Sponsors and Collaborators: |
Medtronic Bakken Research Center Medtronic |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00157781 |
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.
Condition | Intervention | Phase |
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Atrial Fibrillation Atrial Tachyarrhythmia |
Device: Medtronic AT500 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Low Energy in Atrial Fibrillation AF Phase IV Study in AT/AF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker |
Estimated Enrollment: | 237 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | November 2003 |
Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT. The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden, improving QOL and reducing symptoms and costs. Method. 243 pts are implanted with the AT500TM and followed at 1, 7 and 13 months after implant. All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months. One month after implantation patients are randomized either to a six month therapy phase (activation of preventive and ATP pacing) or a six month observation phase (No AT prevention nor Therapy). Crossover (CO) takes place at seven months after implant and the endpoint is reached at 13 months. Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods. At each follow-up, a Save to Disk (STD) of device-stored AT episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Kacet Salem, Prof. | CHU LILLE - FRANCE |
Study Chair: | Mabo Philippe, Prof. | CHU Rennes - France |
Study Chair: | Pisipia André, Dr. | Hopital St Joseph - Marseille - France |
Study Chair: | Frank Robert, Dr. | CHU Pitié-Salpétrière - Paris - France |
Study Chair: | Attuel Patrick, Dr. | Clinique Parly 2 - le Chesnay - France |
Study Chair: | Aliot Etienne, Prof. | CHU Nancy - France |
Study Chair: | le Heuzey Jean Yves, Prof. | HEGP Paris - France |
Study Chair: | Davy Jean Marc, prof. | CHU Montpellier - France |
Study Chair: | Defaye Pascal, Dr | CHU Grenoble - France |
Study ID Numbers: | 124, CP00/63 (CCPPRB Lille France), 2001/08/010 (AFSSAPS France) |
Study First Received: | September 8, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00157781 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Atrial Fibrillation Atrial Tachyarrhythmia Pacing Electrophysiology |
Heart Diseases Tachycardia Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |