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Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease

Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

NCT01170611•LivaNova

Summary

This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

Detailed Description

In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
•A PR interval \<250ms AND
•Documented atrial arrhythmia in the past year
•Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
•Patients must have less than two known cardioversions within the last year
•Patient has signed a consent form after having received the appropriate information

Exclusion Criteria

•Need a replacement pacemaker device
•Have an unknown PR interval
•Known AV block ≥ 250 ms PR interval
•Minor and/or pregnant woman
•Patients enrolled in other clinical trials
•Patients with sustained ventricular arrhythmia
•Patients with severe coronary artery disease (at the discretion of the investigator)
•Patients with advanced cardiomyopathy (at the discretion of the investigator)
•Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
•Patients with unstable angina pectoris
+5 more criteria

Locations (52)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Baywood Heart Hospital

Mesa, Arizona, United States

Brentwood Biomedical Research Institute

Los Angeles, California, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Passaic Beth Israel Regional Medical Center

Passaic, New Jersey, United States

NorthEast Medical Center

Concord, North Carolina, United States

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Lancaster Regional Medical Center

Lancaster, Pennsylvania, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 1, 2004

Completion Date

January 1, 2007

Last Updated

July 27, 2010

Enrollment

400

ACTUAL participants

Conditions

Sinus Node DysfunctionBrady Tachy Syndrome

Interventions

PACEMAKER SYMPHONY 2550

DEVICE

The Fluoroless-CSP Trial Using Electroanatomic Mapping

NCT03903107

Sinus Node DysfunctionHeart Block AV+2 more

View study

COMPLETED

Allometric-Pace Study

NCT05766462

Sinus Node Dysfunction

View study

COMPLETED

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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