Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)

Biotronik

Status

Completed

Conditions

Sick Sinus Syndrome

Treatments

Other: Intrinsic rhythm support (IRSplus)

Other: Ventricular Pace Suppression (Vps)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01528657

BA098

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;
Life expectancy < 12 months;
Cardiac surgery planned within the FU period;
Participation to another clinical investigation;