September 12, 2005 |
December 24, 2008 |
August 2000 |
- 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 ]
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- Incidence of symptomatic and / or persistent re-occurrences of atrial arrhythmias
- Time to first re-occurence of first symptomatic or persistent atrial arrhythmia
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Complete list of historical versions of study NCT00170274 on ClinicalTrials.gov Archive Site |
- 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 ]
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- 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))
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APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias |
Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing |
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. |
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Phase IV |
Interventional |
Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Tachyarrhythmia |
- Device: Activation of preventive and therapeutic algorithms for treatment of AF
- Device: AF Prevention and Therapy Algorithms On
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- No Intervention: Algorithms for prevention and termination of AF not activated
- Active Comparator: Activation of preventive and therapeutic algorithms
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|
|
Active, not recruiting |
180 |
June 2009 |
June 2007 (final data collection date for primary outcome measure) |
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
|
Both |
18 Years and older |
No |
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Germany |
|
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NCT00170274 |
Prof. Dr. med. Wiegand, Sana Klinikum Remscheid |
|
Medtronic Bakken Research Center |
Medtronic |
Principal Investigator: |
Uwe Wiegand, MD |
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck |
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Principal Investigator: |
Christian Wolpert, MD |
Universitätsklinik Mannheim |
|
|
Medtronic Bakken Research Center |
October 2008 |