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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170274
First received: September 12, 2005
Last updated: September 5, 2013
Last verified: September 2013

September 12, 2005
September 5, 2013
August 2000
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence of symptomatic and / or persistent re-occurrences of atrial arrhythmias
  • Time to first re-occurence of first symptomatic or persistent atrial arrhythmia
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 ]
  • 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))
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tachyarrhythmia
  • 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
  • No Intervention: Control Arm
    Algorithms for prevention and termination of AF not activated
  • Active Comparator: Prevention and Therapy Algorithms on
    Activation of preventive and therapeutic algorithms
    Interventions:
    • Device: Activation of preventive and therapeutic algorithms for treatment of AF
    • Device: AF Prevention and Therapy Algorithms On
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
September 2013
June 2011   (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
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00170274
CEN_G_CA_5
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Principal Investigator: Uwe Wiegand, MD Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Principal Investigator: Christian Wolpert, MD Universitätsklinik Mannheim
Medtronic Bakken Research Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP