Back to resultsAPART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
Primary Purpose
Tachyarrhythmia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Activation of preventive and therapeutic algorithms for treatment of AF
AF Prevention and Therapy Algorithms On
Sponsored by
About this trial
This is an interventional treatment trial for Tachyarrhythmia focused on measuring 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
Eligibility 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
Sites / Locations
- Segeberger Kliniken
- Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
- Krankenhaus Marienhof
- Klinikum der Stadt Ludwigshafen
- Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
- Universitätsklinik Mannheim
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Arm
Prevention and Therapy Algorithms on
Arm Description
Algorithms for prevention and termination of AF not activated
Activation of preventive and therapeutic algorithms
Outcomes
Primary Outcome Measures
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia
Secondary Outcome Measures
Atrial fibrillation (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 antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II
Evaluation of possible atrial proarrhythmic effects of the termination algorithms
Cost-efficiency
Incidence in different pacing modes [AAI, DDD(R)]
Full Information
NCT ID
NCT00170274
First Posted
September 12, 2005
Last Updated
January 29, 2018
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00170274
Brief Title
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
Official Title
Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachyarrhythmia
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Algorithms for prevention and termination of AF not activated
Arm Title
Prevention and Therapy Algorithms on
Arm Type
Active Comparator
Arm Description
Activation of preventive and therapeutic algorithms
Intervention Type
Device
Intervention Name(s)
Activation of preventive and therapeutic algorithms for treatment of AF
Intervention Description
Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
Intervention Type
Device
Intervention Name(s)
AF Prevention and Therapy Algorithms On
Intervention Description
Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm
Primary Outcome Measure Information:
Title
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
Time Frame
2 years
Title
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Atrial fibrillation (AF)-burden
Time Frame
2 years
Title
Time interval between persistent episodes during the follow-up period
Time Frame
2 years
Title
Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device
Time Frame
2 years
Title
Quality of life
Time Frame
2 years
Title
Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II
Time Frame
2 years
Title
Evaluation of possible atrial proarrhythmic effects of the termination algorithms
Time Frame
2 years
Title
Cost-efficiency
Time Frame
2 years
Title
Incidence in different pacing modes [AAI, DDD(R)]
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Wiegand, MD
Organizational Affiliation
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Wolpert, MD
Organizational Affiliation
Universitätsklinik Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Segeberger Kliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Krankenhaus Marienhof
City
Koblenz
ZIP/Postal Code
56056
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinik Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
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