NCT00170274

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 3, 2025

Status Verified

January 1, 2018

Enrollment Period

10.8 years

First QC Date

September 12, 2005

Last Update Submit

June 30, 2025

Conditions

Tachyarrhythmia

Keywords

Indication for cardiac pacingAtrial ArrhythmiaIndication for the implantation of a pacemaker according to the German guidelinesDocumented (ECG) atrial tachyarrhythmia within the last three months before enrollment

Outcome Measures

Primary Outcomes (2)

  • Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias

    2 years

  • Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia

    2 years

Secondary Outcomes (8)

  • Atrial fibrillation (AF)-burden

    2 years

  • Time interval between persistent episodes during the follow-up period

    2 years

  • Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device

    2 years

  • Quality of life

    2 years

  • Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Control Arm

NO INTERVENTION

Algorithms for prevention and termination of AF not activated

Prevention and Therapy Algorithms on

ACTIVE COMPARATOR

Activation of preventive and therapeutic algorithms

Device: Activation of preventive and therapeutic algorithms for treatment of AFDevice: AF Prevention and Therapy Algorithms On

Interventions

Activation of preventive and therapeutic algorithms for treatment of AFDEVICE

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

Prevention and Therapy Algorithms on
AF Prevention and Therapy Algorithms OnDEVICE

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

Prevention and Therapy Algorithms on

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen

Essen, 45355, Germany

Location

Krankenhaus Marienhof

Koblenz, 56056, Germany

Location

Klinikum der Stadt Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsklinik Mannheim

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Uwe Wiegand, MD

    Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck

    PRINCIPAL INVESTIGATOR

  • Christian Wolpert, MD

    Universitätsklinik Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2000

Primary Completion

June 1, 2011

Study Completion

October 1, 2014

Last Updated

July 3, 2025

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)