Clinical trial NCT00157781: LEAF - Low Energy In Atrial Fibrillation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Tachyarrhythmia
Keywords: Atrial Fibrillation
Atrial Tachyarrhythmia
Pacing
Electrophysiology
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-12
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Demonstrate that AT 500 algorithms decrease AF Burden
Secondary outcomes:
measure: Characterize the efficiency of prevention and termination algorithms on the Quality of Life of patients
measure: Characterize the correlation between symptoms and stored EGM's
measure: Determine the total number of AF/AT episodes and observe the decrement of their occurrence frequency due to prevention algorithms.
measure: Determine the number of Hospitalization, physician visits…: economical analyze
measure: Analyze the episode onset mechanism
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Kacet Salem, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes,France
name: Mabo Philippe, Prof.
role: STUDY_CHAIR
affiliation: Hopital St Joseph - Marseille - France
name: Pisipia André, Dr.
role: STUDY_CHAIR
affiliation: CHU Pitié-Salpétrière - Paris - France
name: Frank Robert, Dr.
role: STUDY_CHAIR
affiliation: Clinique Parly 2 - le Chesnay - France
name: Attuel Patrick, Dr.
role: STUDY_CHAIR
affiliation: CHU Nancy - France
name: Aliot Etienne, Prof.
role: STUDY_CHAIR
affiliation: HEGP Paris - France
name: le Heuzey Jean Yves, Prof.
role: STUDY_CHAIR
affiliation: CHU Montpellier - France
name: Davy Jean Marc, prof.
role: STUDY_CHAIR
affiliation: CHU Grenoble - France
name: Defaye Pascal, Dr
role: STUDY_CHAIR
References: