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Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

NCT ID: NCT00916344

Last Updated: 2011-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

Detailed Description

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Conditions

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Pacemaker Indication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pacemaker therapy

Group Type EXPERIMENTAL

EVIA Pacemaker

Intervention Type DEVICE

patient has standard indication for pacemaker therapy

Interventions

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EVIA Pacemaker

patient has standard indication for pacemaker therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Patients with chronic atrial fibrillation (dual chamber pacemaker only)
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker
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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Philippe Ritter, Dr.

Role: PRINCIPAL_INVESTIGATOR

CHU Bordeaux Haut-Lévêque

Locations

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CHU Bordeaux Haut-Lévêque

Pessac, Bordeaux, France

Site Status

Countries

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France

Other Identifiers

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38-1

Identifier Type: -

Identifier Source: org_study_id