Ventricular Pace Suppression Study

NCT ID: NCT01053832

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

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Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Detailed Description

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The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Conditions

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Pacemaker Indication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Ventricular Pace Suppression- ON

Group Type OTHER

VpS algorithm in EVIA and ENTOVIS pacemakers

Intervention Type DEVICE

For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.

Ventricular Pace Suppression- OFF

Group Type OTHER

VpS algorithm in EVIA and ENTOVIS pacemakers

Intervention Type DEVICE

For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.

Interventions

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VpS algorithm in EVIA and ENTOVIS pacemakers

For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Paroxysmal AV block and/or Sinus Node Dysfunction
* DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion Criteria

* Permanent AV block III°
* Permanent Atrial Fibrillation/ Flutter
* Require mode other than DDD(R)-ADI(R) or DDD(R)
* Have a life expectancy of less than six months
* Expected to receive heart surgery within six months
* Enrolled in another cardiac investigation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hendrik Bonnemeier, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel

Locations

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Klinikum Coburg gGmbH

Coburg, Bavaria, Germany

Site Status

Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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45

Identifier Type: -

Identifier Source: org_study_id