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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Primary Purpose

Bradycardia, Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

AT501 pacemaker

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Reason for pacing: symptomatic bradycardia Paroxysmal AF (>5 min duration, >3 episodes) post implant of AT501 pacemaker On stable antiarrhythmic drugs Life expectancy >3 years Exclusion Criteria: Life expectancy <3 years Unable to give informed consent Unable to come for followup Chronic AF

Sites / Locations

Foothills Hospital

Outcomes

Primary Outcome Measures

To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term

Secondary Outcome Measures

To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term

Full Information

NCT ID

NCT00123344

First Posted

July 20, 2005

Last Updated

December 10, 2008

Sponsor

University of Calgary

Collaborators

Heart and Stroke Foundation of Ontario

1. Study Identification

Unique Protocol Identification Number

NCT00123344

Brief Title

Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Official Title

Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

December 1999 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

Collaborators

Heart and Stroke Foundation of Ontario

4. Oversight

5. Study Description

Brief Summary

Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs. Drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial tachyarrhythmias is being explored. The AT501 pacemaker has both "prevention" and "treatment" algorithms for atrial tachyarrhythmias. The investigators wish to determine whether these special features, over the long term, decrease the amount of time the person experiences AF.

Detailed Description

There are some clinical and experimental data to suggest that atrial overdrive pacing should prevent AF. In our pacemaker population with tachy-brady syndrome, and in the PA3 study population, we observed that AF frequently clusters and may recur early following an episode of AF. We are conducting a randomized trial of both prevention algorithms and antitachycardia pacing (ATP) therapies for the treatment of atrial tachyarrhythmias and thereby prevention of AF over the longterm. Patients with a history of paroxysmal AF who received an AT501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms "ON", both "OFF" or having only the therapy algorithms "ON". They will be followed every 3 months for 1 year, then every 6 months for an 2 additional years. Recurrence and frequency of AF will be determined over time based on data retrieved from the device at each follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bradycardia, Atrial Fibrillation

Keywords

symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

AT501 pacemaker

Primary Outcome Measure Information:

Title

To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term

Secondary Outcome Measure Information:

Title

To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne M Gillis, MD

Organizational Affiliation

University of Calgary, Professor of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

D. George Wyse, MD, Ph.D

Organizational Affiliation

University of Calgary, Professor of Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

John M Rothschild, MD

Organizational Affiliation

University of Calgary, Professor of Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

M Sarah Rose, Ph D

Organizational Affiliation

University of Calgary, Statistician

Official's Role

Study Chair

Facility Information:

Facility Name

Foothills Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

12. IPD Sharing Statement

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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

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