Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Biotronik SE & Co. KG19 sites in 1 country230 target enrollmentDecember 2011

ConditionsSick Sinus Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sick Sinus Syndrome
Sponsor: Biotronik SE & Co. KG
Enrollment: 230
Locations: 19
Primary Endpoint: Ventricular pacing percentage
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

August 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over 18 years of age;
•Patient has proven informed consent;
•Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
•Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;
•Stable medical situation;
•Stable geographical situation;

Exclusion Criteria

•Permanent or paroxysmal AV block ≥ II;
•Permanent Atrial fibrillation/Atrial flutter;
•Device Replacement;
•Patient with a poor echocardiographic window;
•Patient already implanted with the right ventricular lead not in the apical position;
•Subjects with a dual chamber pacemaker, implanted later than six months;
•Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
•Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
•VpS or IRSplus algorithm contraindications;
•Age \< 18 years;