TachyarrhythmiaNCT00170274
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
A study testing Activation of preventive and therapeutic algorithms for treatment of AF and AF Prevention and Therapy Algorithms On in people with Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia
- What is being tested?
- Activation of preventive and therapeutic algorithms for treatment of AF and AF Prevention and Therapy Algorithms On
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 6 sitesGermany
- Study dates
- Aug 2000to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ejection fraction below 40%
- Mechanic prosthesis of the tricuspid valve
- Indication to implantable cardioverter defibrillator (ICD)-implantation
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Segeberger Kliniken
Bad Segeberg, 23795
Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
Essen, 45355
Krankenhaus Marienhof
Koblenz, 56056
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063
Universitätsklinik Mannheim
Mannheim, 68167
About this study
Official title: 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.
- Conditions
- Tachyarrhythmia
- Being tested
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- 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
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of preventive and therapeutic algorithms for treatment of AFDevice
Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
AF Prevention and Therapy Algorithms OnDevice
Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Algorithms for prevention and termination of AF not activated |
| Prevention and Therapy Algorithms on | Active comparator | Activation of preventive and therapeutic algorithms Receives: Device: Activation of preventive and therapeutic algorithms for treatment of AF; Device: AF Prevention and Therapy Algorithms On |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
Measured: 2 years
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia
Measured: 2 years
Secondary outcomes (8)
Atrial fibrillation (AF)-burden
Measured: 2 years
Time interval between persistent episodes during the follow-up period
Measured: 2 years
Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device
Measured: 2 years
Quality of life
Measured: 2 years
Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II
Measured: 2 years
Evaluation of possible atrial proarrhythmic effects of the termination algorithms
Measured: 2 years
Cost-efficiency
Measured: 2 years
Incidence in different pacing modes [AAI, DDD(R)]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2000
- Primary completionJun 2011
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Uwe Wiegand, MD, Principal investigator, Universitätsklinik Lübeck Schleswig-Holstein, Campus LübeckChristian Wolpert, MD, Principal investigator, Universitätsklinik Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170274
- Sponsor's protocol ID
- CEN_G_CA_5
- Status last verified
- Jan 2018
- First submitted
- 12 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing
- ClinicalTrials.gov ID
- NCT00170274
- Acronym / sponsor ID
- CEN_G_CA_5
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Aug 2000
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Algorithms for prevention and termination of AF not activated |
| Prevention and Therapy Algorithms on | Active comparator | Device: Activation of preventive and therapeutic algorithms for treatment of AF, Device: AF Prevention and Therapy Algorithms OnActivation of preventive and therapeutic algorithms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Ejection fraction below 40%
- Mechanic prosthesis of the tricuspid valve
- Indication to implantable cardioverter defibrillator (ICD)-implantation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation of preventive and therapeutic algorithms for treatment of AFAlgorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation | Device | Prevention and Therapy Algorithms on |
| AF Prevention and Therapy Algorithms OnActivation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm | Device | Prevention and Therapy Algorithms on |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Wiegand, MD principal investigator
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
Christian Wolpert, MD principal investigator
Universitätsklinik Mannheim
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activation of preventive and therapeutic algorithms for treatment of AF and AF Prevention and Therapy Algorithms On in people with Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.