Pacemaker IndicationVpSNCT01053832
Ventricular Pace Suppression Study
A study testing VpS algorithm in EVIA and ENTOVIS pacemakers in people with Pacemaker Indication, run by Biotronik SE & Co. KG at 2 sites in Germany.
Trial summary
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker Indication
- What is being tested?
- VpS algorithm in EVIA and ENTOVIS pacemakers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2010to Sep 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Paroxysmal AV block and/or Sinus Node Dysfunction
- DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability
Who cannot join
- Permanent AV block III°
- Permanent Atrial Fibrillation/ Flutter
- Require mode other than DDD(R)-ADI(R) or DDD(R)
- Have a life expectancy of less than six months
- Expected to receive heart surgery within six months
- Enrolled in another cardiac investigation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinikum Coburg gGmbH
Coburg, Bavaria, 96450
Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
Read the detailed description
The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.
- Conditions
- Pacemaker Indication
- Being tested
- VpS algorithm in EVIA and ENTOVIS pacemakers
- Keywords
- ventricular pace suppression, pacemaker, efficacy, safety, support of intrinsic heart rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VpS algorithm in EVIA and ENTOVIS pacemakersDevice
For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Pace Suppression- ON | Other | Not described Receives: Device: VpS algorithm in EVIA and ENTOVIS pacemakers |
| Ventricular Pace Suppression- OFF | Other | Not described Receives: Device: VpS algorithm in EVIA and ENTOVIS pacemakers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
Measured: 6-8 months
Secondary outcomes (1)
A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker IndicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hendrik Bonnemeier, Prof. Dr., Principal investigator, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053832
- Sponsor's protocol ID
- 45
- Acronym
- VpS
- Status last verified
- Oct 2011
- First submitted
- 19 Jan 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker
- ClinicalTrials.gov ID
- NCT01053832
- Acronym / sponsor ID
- VpS / 45
- Conditions
- Pacemaker Indication
- Keywords
- ventricular pace suppression, pacemaker, efficacy, safety, support of intrinsic heart rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Jan 2010 (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.
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
Detailed description
The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular Pace Suppression- ON | Other | Device: VpS algorithm in EVIA and ENTOVIS pacemakers |
| Ventricular Pace Suppression- OFF | Other | Device: VpS algorithm in EVIA and ENTOVIS pacemakers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Paroxysmal AV block and/or Sinus Node Dysfunction
- DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability
Key exclusion criteria (6 listed)
- Permanent AV block III°
- Permanent Atrial Fibrillation/ Flutter
- Require mode other than DDD(R)-ADI(R) or DDD(R)
- Have a life expectancy of less than six months
- Expected to receive heart surgery within six months
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 |
|---|---|---|
| VpS algorithm in EVIA and ENTOVIS pacemakersFor one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched. | Device | Ventricular Pace Suppression- OFF, Ventricular Pace Suppression- ON |
Primary outcome
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
Time frame: 6-8 months
1 secondary outcome
A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.
Time frame: 6-8 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 25 Oct 2011.
Related trials for Pacemaker Indication
Not yet recruitingObservational study
AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
Recruiting
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Heart Failure, Bradycardia
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.
Hendrik Bonnemeier, Prof. Dr. principal investigator
Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VpS algorithm in EVIA and ENTOVIS pacemakers in people with Pacemaker Indication, run by Biotronik SE & Co. KG at 2 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 6 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 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. (time frame: 6-8 months). 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 25 Oct 2011.