Heart FailureQUARTO_IIINCT02476201
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
A study testing MPP ON in people with Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
Trial summary
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MPP ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
- Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
- In sinus rhythm at baseline visit.
- Patients with Left Bundle Branch Block (LBBB)
- Must be willing and able to comply with study requirements.
- Older than 18 years
- Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.
Who cannot join
- Already has a CRT device implanted.
- Myocardial Infarction or unstable angina within 40 days prior the enrollment.
- New York Heart Association (NYHA) Class IV
- Recent cardiac revascularization in the 4 weeks prior to enrollment.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
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- Primary valvular disease requiring surgical intervention.
- Atrial Fibrillation (AF):
- Persistent AF at the time of enrollment or 30 days prior the enrollment
- Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant
- History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
- Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
- Undergone a cardiac transplantation or being waiting for it
- Life expectancy < 6 months
- Pregnancy or planning to become pregnant
- Unable to comply with the follow up schedule
- Currently participating in any other clinical investigation.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6 Months in CRT Patients Implanted With a Quartet Left Ventricular(LV) Quadripolar Lead and the MultiPoint Pacing (MPP) Feature Activated
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
Read the detailed description
The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.
*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.
- Conditions
- Heart Failure
- Being tested
- MPP ON
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPP ONDevice
Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated
| Study group | Role | What they receive |
|---|---|---|
| MPP ON | Experimental | To activate the Multipoint Pacing (MPP) feature to ON in all patients Receives: Device: MPP ON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CRT Responders
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of >15 % in LVESV, as measured by echocardiography.
Measured: 6 months
Secondary outcomes (4)
Changes in LV Echocardiographic Parameters
An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant.
The values of change with positive numbers represent increases and negative numbers represent decreases.
Measured: Baseline and 6 months
Number of CRT Super-responders
The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of >14% at 6 months post-implant compared to baseline.
Measured: 6 months
Rates of Hospitalization and Mortality
The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant.
Measured: 6 months
Change in NYHA Classification
The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification.
The NYHA provides a simple way of classifying the extent of heart failure:
NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea.
NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea.
NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
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 posted19 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completion13 Feb 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Sanz, Study director, Abbott Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476201
- Sponsor's protocol ID
- CRD_789
- Acronym
- QUARTO_III
- Status last verified
- Feb 2022
- First submitted
- 16 Jun 2015
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6 Months in CRT Patients Implanted With a Quartet Left Ventricular(LV) Quadripolar Lead and the MultiPoint Pacing (MPP) Feature Activated
- ClinicalTrials.gov ID
- NCT02476201
- Acronym / sponsor ID
- QUARTO_III / CRD_789
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
Detailed description
The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.
*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPP ON | Experimental | Device: MPP ONTo activate the Multipoint Pacing (MPP) feature to ON in all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
- Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
- In sinus rhythm at baseline visit.
- Patients with Left Bundle Branch Block (LBBB)
- Must be willing and able to comply with study requirements.
Key exclusion criteria (17 listed)
- Already has a CRT device implanted.
- Myocardial Infarction or unstable angina within 40 days prior the enrollment.
- New York Heart Association (NYHA) Class IV
- Recent cardiac revascularization in the 4 weeks prior to enrollment.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
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 |
|---|---|---|
| MPP ONPatients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated | Device | MPP ON |
Primary outcome
Number of CRT Responders
Time frame: 6 months
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of >15 % in LVESV, as measured by echocardiography.
4 secondary outcomes
Changes in LV Echocardiographic Parameters
Time frame: Baseline and 6 months
Number of CRT Super-responders
Time frame: 6 months
Rates of Hospitalization and Mortality
Time frame: 6 months
Change in NYHA Classification
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Oscar Sanz study director
Abbott Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPP ON in people with Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
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 7 inclusion and 17 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 2 Mar 2022. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of CRT Responders (time frame: 6 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 2 Mar 2022.