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.

Study Overview

• Status: Completed
• Conditions: Tachyarrhythmia
• Intervention / Treatment: Device: Activation of preventive and therapeutic algorithms for treatment of AF; Device: AF Prevention and Therapy Algorithms On

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken
  • Essen, Germany, 45355
    • Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
  • Koblenz, Germany, 56056
    • Krankenhaus Marienhof
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen
  • Lübeck, Germany, 23538
    • Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
  • Mannheim, Germany, 68167
    • Universitätsklinik Mannheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias	2 years
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Uwe Wiegand, MD, Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck; Principal Investigator: Christian Wolpert, MD, Universitätsklinik Mannheim

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Arrhythmia; Indication for cardiac pacing; 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: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: CEN_G_CA_5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO