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

LivaNova

Status and phase

Completed

Phase 4

Conditions

Brady Tachy Syndrome

Sinus Node Dysfunction

Treatments

Device: PACEMAKER SYMPHONY 2550

Study type

Interventional

Funder types

Industry

Identifiers

NCT01170611

PREFACE-IPRE03

IPRE03

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
Patients whose life expectancy is less than 1 year
Patients who are unlikely to return for required follow-up visits
Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
Patient unable to understand the purpose of the study or refusing to cooperate