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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

December 24, 2008

Start Date ^†

August 2000

Current Primary Outcome Measures ^†

Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Incidence of symptomatic and / or persistent re-occurrences of atrial arrhythmias
Time to first re-occurence of first symptomatic or persistent atrial arrhythmia

Change History

Complete list of historical versions of study NCT00170274 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Atrial fibrillation (AF)-burden [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Time interval between persistent episodes during the follow-up period [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluation of possible atrial proarrhythmic effects of the termination algorithms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cost-efficiency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Incidence in different pacing modes [AAI, DDD(R)] [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

AF-Burden
Time interval between persistent episodes during the follow up period
Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device
Quality of life
Necessity and date of a specific antiarrhyhtmic therapy and / or prescription of antiarrhythmic drugs class I and II
Evaluation of possible atrial proarrhythmic effects of the termination algorithms
Cost-efficiency
Incedence in different pacing modes (AAI, DDD(R))

Descriptive Information

Brief Title ^†

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

Official Title ^†

Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Tachyarrhythmia

Intervention ^†

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

Study Arms / Comparison Groups

No Intervention: Algorithms for prevention and termination of AF not activated
Active Comparator: Activation of preventive and therapeutic algorithms

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

180

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00170274

Responsible Party

Prof. Dr. med. Wiegand, Sana Klinikum Remscheid

Secondary IDs ^††

Study Sponsor ^†

Medtronic Bakken Research Center

Collaborators ^††

Medtronic

Investigators ^†

Principal Investigator:	Uwe Wiegand, MD	Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Principal Investigator:	Christian Wolpert, MD	Universitätsklinik Mannheim

Information Provided By

Medtronic Bakken Research Center

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.