Congestive Heart FailureQUOTANCT01850264
Quartet™ Bad Oeynhausen Trial
A study testing Application of quadripolar / bipolar LV electrodes in people with Congestive Heart Failure and Cardiac Resynchronization Therapy, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- Application of quadripolar / bipolar LV electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for CRT-D implantation according to current guidelines
- Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
- Sinus rhythm
- NYHA II-IV
- Age ≥ 18 years
- Written informed consent to participate in the study
Who cannot join
- Right bundle brunch block
- Valvular cardiomyopathy
- Patient receiving a non-transvenous LV electrode
- Known pregnancy
- Age < 18 years
- Life expectancy < 1 year
Show all 10Show fewer
- Atrial fibrillation / atrial flutter at the time of enrolment
- Inability to provide informed consent
- Participation in another study with active therapeutic arm
- Regular follow-up in the study center within the first 6 months after implantation not guaranteed
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Bad Oeynhausen, 32545
About this study
Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)
- Being tested
- Application of quadripolar / bipolar LV electrodes
- Keywords
- cardiac resynchronization therapy; heart failure, congestive
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of quadripolar / bipolar LV electrodesDevice
| Study group | Role | What they receive |
|---|---|---|
| Quadripolar LV electrode | Active comparator | Application of a quadripolar LV electrode Receives: Device: Application of quadripolar / bipolar LV electrodes |
| Bipolar LV electrode | Active comparator | Application of a bipolar LV electrode Receives: Device: Application of quadripolar / bipolar LV electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in peak oxygen consumption
Measured: 6 months
Reduction of New York Heart Association (NYHA) functional class
Measured: 6 months
Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Juergen Gutleben, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Klaus-Juergen Gutleben, M.D., Principal investigator, Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850264
- Sponsor's protocol ID
- HDZNRW_KA_002_KJG
- Acronym
- QUOTA
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2012
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quartet™ Bad Oeynhausen Trial
- ClinicalTrials.gov ID
- NCT01850264
- Acronym / sponsor ID
- QUOTA / HDZNRW_KA_002_KJG
- Keywords
- cardiac resynchronization therapy; heart failure, congestive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 May 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.
Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadripolar LV electrode | Active comparator | Device: Application of quadripolar / bipolar LV electrodesApplication of a quadripolar LV electrode |
| Bipolar LV electrode | Active comparator | Device: Application of quadripolar / bipolar LV electrodesApplication of a bipolar LV electrode |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication for CRT-D implantation according to current guidelines
- Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
- Sinus rhythm
- NYHA II-IV
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Right bundle brunch block
- Valvular cardiomyopathy
- Patient receiving a non-transvenous LV electrode
- Known pregnancy
- Age < 18 years
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 |
|---|---|---|
| Application of quadripolar / bipolar LV electrodes | Device | Bipolar LV electrode, Quadripolar LV electrode |
Primary outcome
Increase in peak oxygen consumption
Time frame: 6 months
Reduction of New York Heart Association (NYHA) functional class
Time frame: 6 months
Survival
Time frame: 6 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 30 Jan 2019.
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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-Juergen Gutleben, M.D. principal investigator
Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of quadripolar / bipolar LV electrodes in people with Congestive Heart Failure and 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 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: finished, as of the sponsor's last update on 30 Jan 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 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?
Increase in peak oxygen consumption (time frame: 6 months). The study lists 3 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 30 Jan 2019.