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Adapta Pacing System Clinical Study

NCT ID: NCT00307073

Last Updated: 2006-10-12

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-11-30

Brief Summary

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Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.

Detailed Description

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Conditions

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Pacemaker Bradycardia

Keywords

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Pacemaker Managed Ventricular Pacing Ventricular Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Implantable Pulse Generator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
* Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form

Exclusion Criteria

* Subjects with a mechanical tricuspid valve
* Subjects with a life expectancy less than two years
* Subjects with a Class III indication for permanent pacing
* Subjects with lead integrity problems, unless leads are being replaced
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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Adapta Study Team

Role: STUDY_CHAIR

Medtronic

Locations

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Graz, , Austria

Site Status

Prague, , Czechia

Site Status

Bad Nauheim, , Germany

Site Status

Hamburg, , Germany

Site Status

Heerlen, , Netherlands

Site Status

Belgrade, , Serbia and Montenegro

Site Status

Lund, , Sweden

Site Status

Countries

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Austria Czechia Germany Netherlands Serbia and Montenegro Sweden

Other Identifiers

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201

Identifier Type: -

Identifier Source: org_study_id