LEAF - Low Energy In Atrial Fibrillation

January 29, 2018 updated by: Medtronic Bakken Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

237

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstrate that AT 500 algorithms decrease AF Burden

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion

November 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124
  • CP00/63 (CCPPRB Lille France)
  • 2001/08/010 (AFSSAPS France)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Medtronic AT500

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe