APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias

NCT ID: NCT00170274

Last Updated: 2025-07-03

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

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2014-10-31

Brief Summary

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The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.

Detailed Description

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Conditions

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Tachyarrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm

Algorithms for prevention and termination of AF not activated

Group Type NO_INTERVENTION

No interventions assigned to this group

Prevention and Therapy Algorithms on

Activation of preventive and therapeutic algorithms

Group Type ACTIVE_COMPARATOR

Activation of preventive and therapeutic algorithms for treatment of AF

Intervention Type DEVICE

Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation

AF Prevention and Therapy Algorithms On

Intervention Type DEVICE

Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Interventions

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Activation of preventive and therapeutic algorithms for treatment of AF

Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation

Intervention Type DEVICE

AF Prevention and Therapy Algorithms On

Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for cardiac pacing according to the German guidelines
* Documented (electrocardiogram; ECG) atrial arrhythmia during the last three months before enrollment
* Willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia
* Sinus rhythm during 24 hours before implant of the device

Exclusion Criteria

* Ejection fraction below 40%
* Mechanic prosthesis of the tricuspid valve
* Indication to implantable cardioverter defibrillator (ICD)-implantation
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uwe Wiegand, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck

Christian Wolpert, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Mannheim

Locations

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Segeberger Kliniken

Bad Segeberg, , Germany

Site Status

Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen

Essen, , Germany

Site Status

Krankenhaus Marienhof

Koblenz, , Germany

Site Status

Klinikum der Stadt Ludwigshafen

Ludwigshafen, , Germany

Site Status

Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Site Status

Universitätsklinik Mannheim

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CEN_G_CA_5

Identifier Type: -

Identifier Source: org_study_id

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