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

Tachyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170274
• Other study ID #: CEN_G_CA_5
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 29, 2018
• Start date: August 2000
• Est. completion date: October 2014

Study information

• Verified date: January 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachyarrhythmia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Device:
• Activation of preventive and therapeutic algorithms for treatment of AF
Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
• AF Prevention and Therapy Algorithms On
Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Locations

Country	Name	City	State
Germany	Segeberger Kliniken	Bad Segeberg
Germany	Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen	Essen
Germany	Krankenhaus Marienhof	Koblenz
Germany	Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck	Lübeck
Germany	Klinikum der Stadt Ludwigshafen	Ludwigshafen
Germany	Universitätsklinik Mannheim	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias		2 years
Primary	Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia		2 years
Secondary	Atrial fibrillation (AF)-burden		2 years
Secondary	Time interval between persistent episodes during the follow-up period		2 years
Secondary	Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device		2 years
Secondary	Quality of life		2 years
Secondary	Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II		2 years
Secondary	Evaluation of possible atrial proarrhythmic effects of the termination algorithms		2 years
Secondary	Cost-efficiency		2 years
Secondary	Incidence in different pacing modes [AAI, DDD(R)]		2 years