Pacemaker Implantation for Sinus Node DiseaseADVANTAGENCT01803217

Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

A study testing pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function in people with Pacemaker Implantation for Sinus Node Disease, run by Deutsches Herzzentrum Muenchen at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators. The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pacemaker Implantation for Sinus Node Disease
What is being tested?: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 3 sitesGermany
Study dates: Nov 2007to Jun 2016
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 the implantation of a dual-chamber pacemaker

Who cannot join

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Klinikum Bamberg
Bamberg, Bavaria, 96049
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
München, Bavaria, 80636
Krankenhaus Peißenberg
Peißenberg, Bavaria, 82380

Other trials in Germany

About this study

Official title: AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Read the detailed description

Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Conditions: Pacemaker Implantation for Sinus Node Disease
Being tested: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis functionOther

Study groups in NCT01803217
Study group	Role	What they receive
mode switch to atrial pacing	Experimental	Not described Receives: Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
atrioventricular hysteresis function	Active comparator	Not described Receives: Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

What is being measured

The primary outcome is the main question the study is designed to answer.

Right ventricular pacing percentage
Measured: 3 months

Secondary outcomes (1)

BNP levels
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Jun 2016

First posted4 Mar 2013 (estimated)
Study startNov 2007
Primary completionDec 2011
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pacemaker Implantation for Sinus Node DiseaseStudies of the same condition, open and under way.
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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01803217
Sponsor's protocol ID: GER-EP-010
Acronym: ADVANTAGE
Status last verified: Apr 2017
First submitted: 28 Feb 2013
Last updated: 10 Apr 2017
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing
ClinicalTrials.gov ID: NCT01803217
Acronym / sponsor ID: ADVANTAGE / GER-EP-010
Conditions: Pacemaker Implantation for Sinus Node Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Deutsches Herzzentrum MuenchenUniversity, hospital or other
Collaborators: Klinikum Bamberg, Krankenhaus Peißenberg, Medtronic
Study start: Nov 2007 (actual)
Primary completion: Dec 2011 (actual)
Study completion: Jun 2016 (actual)
First posted: 4 Mar 2013 (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.

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
mode switch to atrial pacing	Experimental	Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
atrioventricular hysteresis function	Active comparator	Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Indication for the implantation of a dual-chamber pacemaker

Key exclusion criteria (1 listed)

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

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
pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function	Other	atrioventricular hysteresis function, mode switch to atrial pacing

Primary outcome

Right ventricular pacing percentage
Time frame: 3 months

1 secondary outcome

BNP levels
Time frame: 3 months

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 10 Apr 2017.

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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Right ventricular pacing percentage (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01803217.

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 10 Apr 2017.