At a glance

ClinicalIndex Comparison Record

N/ACompleted· 230 enrolled

Drug / intervention

Ventricular Pace Suppression (Vps) +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528657

NCT01528657N/ACompleted

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Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Biotronik SE & Co. KG·interventional·Posted Feb 8, 2012·Updated Oct 22, 2015

In Brief

A clinical study evaluating Ventricular Pace Suppression (Vps) and Intrinsic rhythm support (IRSplus) for Sick Sinus Syndrome. Completed, enrolled 230 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSick Sinus Syndrome

CountriesItaly

Collaborators--

Timeline

N/ACompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartDec 2011

First PostedFeb 2012

Primary CompletionAug 2015

TodayJul 2026

First PostedFeb 8, 2012

Enrollment StartDec 1, 2011

Primary CompletionAug 1, 2015

TodayJul 2, 2026

Enrollment to primary: 3.7 yearsPosted 14.4 years ago

Interventions

Ventricular Pace Suppression (Vps)other

Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.

Intrinsic rhythm support (IRSplus)other

All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.