Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)

This study is currently recruiting participants.
Verified September 2012 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01528657
First received: February 6, 2012
Last updated: September 28, 2012
Last verified: September 2012
  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 AV 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: July 2014
Estimated Primary Completion Date: December 2013 (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 RV lead in the apical position;
  • Stable medical situation;
  • Stable geographical situation;

Exclusion Criteria:

  • Permanent or paroxysmal AV block ≥ II;
  • Permanent AF/Afl;
  • Device Replacement;
  • Patient with a poor echocardiographic window;
  • Patient already implanted with the RV 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

Contacts
Contact: Nicola Rovai +393346379010 nicola.rovai@biotronik.com
Contact: Francesco Chiusso +393346777837 francesco.chiusso@biotronik.com

Locations
Italy
Ospedale Bolognini Recruiting
Seriate, Bergamo, Italy
Principal Investigator: Vittorio Giudici            
P.O. F. Ferrari Recruiting
Casarano, Lecce, Italy
Principal Investigator: Donato Melissano            
A.O. Destra Secchia Recruiting
Pieve di Coriano, Mantova, Italy
Principal Investigator: Mario Pasqualini            
Ospedale San Leonardo Recruiting
Castellammare, Napoli, Italy
Principal Investigator: Ciro Guastaferro            
Ospedale SS. Trinità Not yet recruiting
Borgomanero, Novara, Italy
Principal Investigator: Stefano Maffè            
Ospedale SS. Cosma e Damiano Not yet recruiting
Pescia, Pistoia, Italy
Principal Investigator: Massimo Lupetti            
Ospedale Santa Croce Not yet recruiting
Moncalieri, Torino, Italy
Principal Investigator: Catia Checchinato            
Ospedale S.Antonio Abate Recruiting
Gallarate, Varese, Italy
Principal Investigator: Daniela Orsida            
Ospedale Dell'Angelo Not yet recruiting
Mestre, Venezia, Italy
Principal Investigator: Michela Madalosso            
A.O.U. Ospedali Riuniti di Ancona Not yet recruiting
Ancona, Italy
Principal Investigator: Alessandro Capucci            
Ospedale Degli Infermi Recruiting
Biella, Italy
Principal Investigator: Marenna Biondino            
A.O.U. Policlinico-Vittorio Emanuele Recruiting
Catania, Italy
Principal Investigator: Valeria Calvi            
Ospedale S. Giuseppe Not yet recruiting
Empoli, Italy
Principal Investigator: Attilio Del Rosso            
Osp. Civile F. Veneziale Recruiting
Isernia, Italy
Principal Investigator: Bruno Castaldi            
P.O. Vito Fazzi Recruiting
Lecce, Italy
Principal Investigator: Francesco Magliari            
A.O.R.N. dei Colli - PO "V. Monaldi" Recruiting
Napoli, Italy
Principal Investigator: Gerardo Nigro            
Policlinico Universitario di Padova Not yet recruiting
Padova, Italy
Principal Investigator: Loira Leoni            
A.O. Santa Maria Degli Angeli Recruiting
Pordenone, Italy
Principal Investigator: Marco Brieda            
A.O. San Carlo Not yet recruiting
Potenza, Italy
Principal Investigator: Francesco Sisto            
Ospedale Degli Infermi Not yet recruiting
Rimini, Italy
Principal Investigator: Maurizio Mezzetti            
Ospedale SS. Giovanni e Paolo Recruiting
Venezia, Italy
Principal Investigator: Andrea Lo Presti            
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: September 28, 2012
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 May 23, 2013