Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01528657
First received: February 6, 2012
Last updated: January 17, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention
Sick Sinus Syndrome
Other: Ventricular Pace Suppression (Vps)
Other: Intrinsic rhythm support (IRSplus)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Ventricular pacing percentage [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term atrio-ventricular conduction delay [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Occurrence of atrial tachycardia or atrial fibrillation events [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Burden of atrial fibrillation [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: December 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • Life expectancy < 12 months;
  • Cardiac surgery planned within the FU period;
  • Participation to another clinical investigation;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528657

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

Publications:

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01528657     History of Changes
Other Study ID Numbers: BA098
Study First Received: February 6, 2012
Last Updated: January 17, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Biotronik SE & Co. KG:
Sick Sinus Syndrome
Ventricular pacing
Minimal ventricular pacing
Ventricular pacing suppression
Intrinsic rhythm support
Long term AV

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014