LEAF - Low Energy In Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157781
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 30, 2018
Information provided by:
Medtronic Bakken Research Center

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Tachyarrhythmia Device: Medtronic AT500 Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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
Study Start Date : August 2000
Estimated Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Demonstrate that AT 500 algorithms decrease AF Burden

Secondary Outcome Measures :
  1. Characterize the efficiency of prevention and termination algorithms on the Quality of Life of patients
  2. Characterize the correlation between symptoms and stored EGM's
  3. Determine the total number of AF/AT episodes and observe the decrement of their occurrence frequency due to prevention algorithms.
  4. Determine the number of Hospitalization, physician visits…: economical analyze
  5. Analyze the episode onset mechanism

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.

Exclusion Criteria:

  • Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157781

Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Kacet Salem, Prof. University Hospital, Lille
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 Identifier: NCT00157781     History of Changes
Other Study ID Numbers: 124
CP00/63 (CCPPRB Lille France)
2001/08/010 (AFSSAPS France)
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Medtronic Bakken Research Center:
Atrial Fibrillation
Atrial Tachyarrhythmia

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes