LEAF - Low Energy In Atrial Fibrillation

This study has been terminated.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00157781
First received: September 8, 2005
Last updated: September 13, 2005
Last verified: September 2005
  Purpose

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
Atrial Fibrillation
Atrial Tachyarrhythmia
Device: Medtronic AT500
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

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

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

Estimated Enrollment: 237
Study Start Date: August 2000
Estimated Study Completion Date: November 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157781

Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157781     History of Changes
Other 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 21, 2014