Cardiac Resynchronization TherapyVECTOPTNCT03092349
SonR Based Stimulation-VECtor OPTimisation in CRT Patients
An observational study of Cardiac Resynchronization Therapy, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- Vector optimisation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to 31 Dec 2018
- Phase
- Observational
- 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
Study population: Patients with a CRT-D system providing the possibility of SonR-based optimisation of AV-D and VV-D
Who may be able to join
- Indication for CRT-D implantation according to guidelines at the time of implantation
- Implanted CRT-D system with SonR sensor technology
- Sinus rhythm
- NYHA class II-IV
- Age ≥ 18 years
- Written informed consent to participate in the study
Who cannot join
- Patients having received a CRT system without SonR sensor technology
- Patients with an insufficient SonR signal
- Confirmed pregnancy
- Age < 18 years
- Life expectancy < 1 year
- Atrial fibrillation / atrial flutter at the time of enrollment
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- Unability to give informed consent
- Participation in another clinical study with active therapeutic arm
- Regular follow-up at the study site from enrolment to 12 months follow up not guaranteed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of SonR Based Stimulation-VECtor OPTimisation in Patients With Chronically Implanted Cardiac Resynchronization Devices
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- Vector optimisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vector optimisationDevice
Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP decrease (-15%)
Measured: 12 months
VO2max (+ ≥0.7 ml/min/kg)
Measured: 12 months
NYHA class (improvement by ≥ 1 class)
Measured: 12 months
QOL (MLHF), score reduction (-15)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startJan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Principal Investigator has left study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus-Jürgen Gutleben, MD, Principal investigator, Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092349
- Sponsor's protocol ID
- HDZNRW-KA-007_KJG
- Acronym
- VECTOPT
- Status last verified
- Jan 2019
- First submitted
- 21 Mar 2017
- Last updated
- 6 Feb 2019
- 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 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SonR Based Stimulation-VECtor OPTimisation in Patients With Chronically Implanted Cardiac Resynchronization Devices
- ClinicalTrials.gov ID
- NCT03092349
- Acronym / sponsor ID
- VECTOPT / HDZNRW-KA-007_KJG
- Conditions
- Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator has left study site
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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 primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a CRT-D system providing the possibility of SonR-based optimisation of AV-D and VV-D
Key inclusion criteria (6 listed)
- Indication for CRT-D implantation according to guidelines at the time of implantation
- Implanted CRT-D system with SonR sensor technology
- Sinus rhythm
- NYHA class II-IV
- Age ≥ 18 years
Key exclusion criteria (9 listed)
- Patients having received a CRT system without SonR sensor technology
- Patients with an insufficient SonR signal
- Confirmed pregnancy
- Age < 18 years
- Life expectancy < 1 year
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 |
|---|---|---|
| Vector optimisationEvaluation of hemodynamically best LV Stimulation vector and device programming according to measurements | Device | – |
Primary outcome
NT-proBNP decrease (-15%)
Time frame: 12 months
VO2max (+ ≥0.7 ml/min/kg)
Time frame: 12 months
NYHA class (improvement by ≥ 1 class)
Time frame: 12 months
QOL (MLHF), score reduction (-15)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Principal Investigator has left study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- 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.
Klaus-Jürgen Gutleben, MD principal investigator
Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization Therapy, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site 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 6 inclusion and 9 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Principal Investigator has left study site). 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?
NT-proBNP decrease (-15%) (time frame: 12 months). The study lists 4 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 6 Feb 2019.