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

September 8, 2005
September 13, 2005
August 2000
Not Provided
Demonstrate that AT 500 algorithms decrease AF Burden
Same as current
Complete list of historical versions of study NCT00157781 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
LEAF - Low Energy In Atrial Fibrillation
Low Energy in Atrial Fibrillation AF Phase IV Study in AT/AF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Tachyarrhythmia
Device: Medtronic AT500
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
237
November 2003
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00157781
124, CP00/63 (CCPPRB Lille France), 2001/08/010 (AFSSAPS France)
Not Provided
Not Provided
Medtronic Bakken Research Center
Medtronic
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
Medtronic Bakken Research Center
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP