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

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00170274

Purpose

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.

Condition	Intervention	Phase
Tachyarrhythmia	Device: Activation of preventive and therapeutic algorithms for treatment of AF Device: AF Prevention and Therapy Algorithms On	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing

Further study details as provided by Medtronic Bakken Research Center:

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 ]

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 ]

Estimated Enrollment:	180
Study Start Date:	August 2000
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 AF Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation Device: AF Prevention and Therapy Algorithms On Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170274

Locations

Germany
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Universitätsklinik Mannheim
Mannnheim, Germany, 68167
Segeberger Kliniken
Bad Segeberg, Germany, 23795
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063
Krankenhaus Marienhof
Koblenz, Germany, 56056
Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
Essen, Germany, 45355

Sponsors and Collaborators

Medtronic Bakken Research Center

Medtronic

Investigators

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

More Information

Responsible Party:	Sana Klinikum Remscheid ( Prof. Dr. med. Wiegand )
Study ID Numbers:	CEN_G_CA_5
Study First Received:	September 12, 2005
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00170274
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

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

Study placed in the following topic categories:

Tachycardia, Supraventricular
Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009