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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: May 10, 2013
Last verified: May 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing

Resource links provided by NLM:

U.S. FDA Resources

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: September 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
Segeberger Kliniken
Bad Segeberg, Germany, 23795
Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
Essen, Germany, 45355
Krankenhaus Marienhof
Koblenz, Germany, 56056
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Universitätsklinik Mannheim
Mannnheim, Germany, 68167
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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00170274     History of Changes
Other Study ID Numbers: CEN_G_CA_5
Study First Received: September 12, 2005
Last Updated: May 10, 2013
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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Tachycardia, Supraventricular
Tachycardia
Atrial Premature Complexes
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature

ClinicalTrials.gov processed this record on May 16, 2013