NCT00157781

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2000

Typical duration for phase_4 atrial-fibrillation

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

July 3, 2025

Status Verified

January 1, 2018

First QC Date

September 8, 2005

Last Update Submit

June 30, 2025

Conditions

Atrial FibrillationAtrial Tachyarrhythmia

Keywords

Atrial FibrillationAtrial TachyarrhythmiaPacingElectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Demonstrate that AT 500 algorithms decrease AF Burden

Secondary Outcomes (5)

  • 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

Interventions

Medtronic AT500DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kacet Salem, Prof.

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2000

Study Completion

November 1, 2003

Last Updated

July 3, 2025

Record last verified: 2018-01