Clinical trial NCT00170274: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachyarrhythmia
Keywords: Indication for cardiac pacing
Atrial Arrhythmia
Indication for the implantation of a pacemaker according to the German guidelines
Documented (ECG) atrial tachyarrhythmia within the last three months before enrollment
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-15
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
timeFrame: 2 years
measure: Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia
timeFrame: 2 years
Secondary outcomes:
measure: Atrial fibrillation (AF)-burden
timeFrame: 2 years
measure: Time interval between persistent episodes during the follow-up period
timeFrame: 2 years
measure: Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II
timeFrame: 2 years
measure: Evaluation of possible atrial proarrhythmic effects of the termination algorithms
timeFrame: 2 years
measure: Cost-efficiency
timeFrame: 2 years
measure: Incidence in different pacing modes [AAI, DDD(R)]
timeFrame: 2 years
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Essen
country: Germany
facility: Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
city: Koblenz
country: Germany
facility: Krankenhaus Marienhof
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Lübeck
country: Germany
facility: Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
city: Mannheim
country: Germany
facility: Universitätsklinik Mannheim
Study officials:
affiliation: Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
name: Uwe Wiegand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinik Mannheim
name: Christian Wolpert, MD
role: PRINCIPAL_INVESTIGATOR
References: