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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Ventricular pacing percentage
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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