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Completed

NCT Number: NCT01528657

Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

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.

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Key information

Conditions

Sick Sinus Syndrome Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Bolognini, Seriate, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Ventricular pacing percentage

    Time frame: 6 months

Secondary outcomes

  1. Long-term atrio-ventricular conduction delay

    Time frame: 6 Months

  2. Occurrence of atrial tachycardia or atrial fibrillation events

    Time frame: 6 Months

  3. Burden of atrial fibrillation

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: VIPERS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2012
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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