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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170274
First Posted: September 15, 2005
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]
  • Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Atrial fibrillation (AF)-burden [ Time Frame: 2 years ]
  • Time interval between persistent episodes during the follow-up period [ Time Frame: 2 years ]
  • Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device [ Time Frame: 2 years ]
  • Quality of life [ Time Frame: 2 years ]
  • Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II [ Time Frame: 2 years ]
  • Evaluation of possible atrial proarrhythmic effects of the termination algorithms [ Time Frame: 2 years ]
  • Cost-efficiency [ Time Frame: 2 years ]
  • Incidence in different pacing modes [AAI, DDD(R)] [ Time Frame: 2 years ]

Enrollment: 156
Study Start Date: August 2000
Study Completion Date: October 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00170274     History of Changes
Other Study ID Numbers: CEN_G_CA_5
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes