Arrhythmia, SinusPhase 4NCT00157794
EnTRINSIC - EnPulse Trial on Search AV+ Influence
A Phase 4 study testing Search AV+ algorithm in people with Arrhythmia, Sinus, run by Medtronic Cardiac Rhythm and Heart Failure at 14 sites in Germany.
Trial summary
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Sinus
- What is being tested?
- Search AV+ algorithm
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 14 sitesGermany
- Study dates
- Feb 2004to Nov 2007
- Phase
- Phase 4
- 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
- Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
- Patients treated with a Medtronic pacemaker with Search AV+ algorithm
Who cannot join
- Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction
- New York Heart Association (NYHA) III/IV
- Instable angina pectoris
- Heart valve vitium
- Persistent AV-block II and III
- Early diastolic mitral regurgitation
Show all 10Show fewer
- Implantable cardioverter defibrillator
- Participation in other clinical studies
- Pregnancy or unreliable birth control
- AV-block under strain
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Internistische Praxis Dr. Med. Schade
Berlin, 13187
St. Josefs Hospital
Bochum, 44791
Praxis Dr. Med. Markert
Gaggenau, 76571
Krankenhaus Martha Maria Halle
Halle
Universitätsklinikum Heidelberg
Heidelberg, 69120
St. Vincentius Kliniken
Karlsruhe, 76135
Vinzentius Krankenhaus
Landau, 76829
Klinikum der Johannes-Gutenberg-Universität
Mainz, 55131
Klinikum Großhadern Herzchirurgische Klinik und Poliklinik
Munich, Bavaria, 81377
Städtisches Klinikum Neunkirchen
Neunkirchen, 66538
Kreiskrankenhaus Ottweiler
Ottweiler, 66564
Knappschaftskrankenhaus Sulzbach, Medizinische Klinik
Sulzbach, 66280
Josephs-Hospital
Warendorf, 48231
Gemeinschaftspraxis Dr. Tamm/Dr. Hon
Wittenberg
About this study
Official title: EnPulse Trial on Search AV+ Influence
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
- Conditions
- Arrhythmia, Sinus
- Being tested
- Search AV+ algorithm
- Keywords
- Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker
- Medical subject headings
- Arrhythmia, Sinus, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search AV+ algorithmDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of right ventricular pacing
Measured: Baseline to 36 months post-implant
Secondary outcomes (4)
Change in intrinsic AV delay
Measured: Baseline to 36 months post-implant
Hospitalizations because of symptomatic heart failure
Measured: Baseline to 36 months post-implant
Hospitalizations because of symptomatic atrial fibrillation
Measured: Baseline to 36 months post-implant
Medication
Measured: Baseline to 36 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia, SinusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 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
- Michael Jakob, MD, Principal investigator, Knappschaftskrankenhaus SulzbachPeter Lamm, MD, Principal investigator, Klinikum der Universität München Großhadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157794
- Sponsor's protocol ID
- CEN_G_CA_2
- Status last verified
- Feb 2017
- First submitted
- 9 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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
- EnPulse Trial on Search AV+ Influence
- ClinicalTrials.gov ID
- NCT00157794
- Acronym / sponsor ID
- CEN_G_CA_2
- Conditions
- Arrhythmia, Sinus
- Keywords
- Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Feb 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 12 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.
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
- Patients treated with a Medtronic pacemaker with Search AV+ algorithm
Key exclusion criteria (10 listed)
- Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction
- New York Heart Association (NYHA) III/IV
- Instable angina pectoris
- Heart valve vitium
- Persistent AV-block II and III
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 |
|---|---|---|
| Search AV+ algorithm | Device | – |
Primary outcome
Amount of right ventricular pacing
Time frame: Baseline to 36 months post-implant
4 secondary outcomes
Change in intrinsic AV delay
Time frame: Baseline to 36 months post-implant
Hospitalizations because of symptomatic heart failure
Time frame: Baseline to 36 months post-implant
Hospitalizations because of symptomatic atrial fibrillation
Time frame: Baseline to 36 months post-implant
Medication
Time frame: Baseline to 36 months post-implant
Results and safety
The study was stopped early (reason given: Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Knappschaftskrankenhaus SulzbachLink provided by the sponsor.
- Klinikum der Universität München -GroßhadernLink provided by the sponsor.
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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.
Michael Jakob, MD principal investigator
Knappschaftskrankenhaus Sulzbach
Peter Lamm, MD principal investigator
Klinikum der Universität München Großhadern
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Search AV+ algorithm in people with Arrhythmia, Sinus, run by Medtronic Cardiac Rhythm and Heart Failure at 14 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 2 inclusion and 10 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: stopped early, 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 14 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.). Results are not available in the source record.
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?
Amount of right ventricular pacing (time frame: Baseline to 36 months post-implant). 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.