Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)

October 21, 2015 updated by: Biotronik SE & Co. KG
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • A.O.U. Ospedali Riuniti di Ancona
      • Biella, Italy
        • Ospedale degli Infermi
      • Catania, Italy
        • A.O.U. Policlinico-Vittorio Emanuele
      • Empoli, Italy
        • Ospedale S. Giuseppe
      • Isernia, Italy
        • Osp. Civile F. Veneziale
      • Lecce, Italy
        • P.O. Vito Fazzi
      • Napoli, Italy
        • A.O.R.N. dei Colli - PO "V. Monaldi"
      • Pordenone, Italy
        • A.O. Santa Maria degli Angeli
      • Potenza, Italy
        • A.O. San Carlo
      • Rimini, Italy
        • Ospedale degli Infermi
      • Venezia, Italy
        • Ospedale Ss. Giovanni e Paolo
    • Bergamo
      • Seriate, Bergamo, Italy
        • Ospedale Bolognini
    • Lecce
      • Casarano, Lecce, Italy
        • P.O. F. Ferrari
    • Mantova
      • Pieve di Coriano, Mantova, Italy
        • A.O. Destra Secchia
    • Napoli
      • Castellammare, Napoli, Italy
        • Ospedale San Leonardo
    • Novara
      • Borgomanero, Novara, Italy
        • Ospedale SS. Trinità
    • Pistoia
      • Pescia, Pistoia, Italy
        • Ospedale SS. Cosma e Damiano
    • Torino
      • Moncalieri, Torino, Italy
        • Ospedale Santa Croce
    • Varese
      • Gallarate, Varese, Italy
        • Ospedale S.Antonio Abate
    • Venezia
      • Mestre, Venezia, Italy
        • Ospedale dell'Angelo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ventricular Pace Suppression (VpS)
The function Ventricular Pace Suppression (VpS) is activated
Other: Ventricular Pace Suppression (Vps)
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.
Experimental: Intrinsic Rhythm Support (IRSplus)
The function Intrinsic Rhythm Support (IRSplus) is activated
Other: Intrinsic rhythm support (IRSplus)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventricular pacing percentage
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term atrio-ventricular conduction delay
Time Frame: 6 Months
6 Months
Occurrence of atrial tachycardia or atrial fibrillation events
Time Frame: 6 Months
6 Months
Burden of atrial fibrillation
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Alessandro Capucci, A.O.U. Ospedali Riuniti, Ancona
  • Principal Investigator: Valeria Calvi, A.O.U. Policlinico-Vittorio Emanuele, Catania
  • Principal Investigator: Marco Brieda, A.O. Santa Maria degli Angeli, Pordenone
  • Principal Investigator: Ennio Pisanò, P.O. Vito Fazzi, Lecce
  • Principal Investigator: Vittorio Giudici, Ospedale Bolognini, Seriate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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