Cardiac Resynchronization Therapy, Non-LBBB, QRS AreaMARC-2NCT04120909
MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB
An observational study of Cardiac Resynchronization Therapy, Non-LBBB, QRS Area, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the MARC-2 study is to investigate the relation of the QRS area, determined by vectorcardiography, and response to Cardiac Resynchronization Therapy (CRT) in patients with a wide QRS complex and without a typical left bundle branch block; the interrelationship as well as the potential predictive power… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy, Non-LBBB, QRS Area
- What is being tested?
- Cardiac resynchronization therapy
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Aug 2019to Aug 2022
- 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
- Adult, Older adult
Study population: The study group to be recruited will consist of heart failure patients (NYHA I-IV), male and female, with a reduced left ventricular ejection fraction (LVEF</=35%) and ventricular dyssynchrony (QRS>/=130ms) as measured prior to implantation of a CRT device. Each study subject receives a CRT device with a class I or II indication according to the current CRT ESC/AHA guidelines.
Who may be able to join
- Subject is scheduled to be implanted with a CRT-pacemaker or CRT-defibrillator
- Subject has NYHA class I, II, III or ambulant IV
- Subject has LV dysfunction (LVEF</=35%)
- Subject is in sinus rhythm on an ECG less than 45 days before CRT implantation
- Intrinsic QRS duration is >/=130ms (of either QRS morphology) within 30 days prior to CRT device implantation
- Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrolment
- Subject is willing to sign informed consent form
- Subject is 18 years or older
Who cannot join
- Subject has a pacemaker/ICD with >5% RV pacing.
- Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
- Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
- Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
- Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- Subject is implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
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- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
- Subject has permanent 2nd or 3rd degree AV-block
- Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
- Subject has complex and uncorrected congenital heart disease
- Subject has a mechanical right heart valve
- Subject has a life expectancy of less than one year in the opinion of the investigator
- Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- Subject is enrolled in one or more concurrent studies that would confound the results of this study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC+
Maastricht
Mohammed Ghossein, drs., +31(0)433884520, mohammed.ghossein@mumc.nl
About this study
The purpose of the MARC-2 study is to investigate the relation of the QRS area, determined by vectorcardiography, and response to Cardiac Resynchronization Therapy (CRT) in patients with a wide QRS complex and without a typical left bundle branch block; the interrelationship as well as the potential predictive power of this biomarker, as well as other clinical biomarkers on a hierarchal composite endpoint (death, heart failure hospitalizations, heart failure complaints and cardiac function) will be evaluated.
The main biomarker that is studied is the QRS area, but also other electrocardiographic, echocardiographic markers, blood markers and clinical markers will be studied.
Read the detailed description
For the purpose described in the brief summary, the MARC-2 study investigators have set an aim of including 800 patients in 2 inclusion years, in 30 centres accross Europe and Israel. Inclusion will be general patients indicated for (de novo or upgrade) implantation a (Medtronic) CRT-pacemaker or -ICD, as according to current ESC heart failure guidelines. Exclusion criteria are, age below 18 years, (planning) childbearing, baseline > 5% RV-pacing, listing for transplantation or inotropic dependency, structural heart disease for which invasive therapy is pending, or inability/unwillingness to sign written informed consent. All QRS morphologies, with duration >/= 130ms are included because multiple LBBB definitions exist and excluding patients on one definition will leave room for questions about the definitions used. (Bio)markers that are collected are electrocardiographic/vectorcardiographic/echocardiographic/blood-/CMR/ and device-based parameters that have shown prior association to outcomes in CRT, with special attention to vectorcardiographic QRS area. The primary endpoint will be a hierarchal (Packer) score of collected heart failure related endpoints including death/LVAD/cardiac transpland/heart failure hospitalizations/echocardiographic remodelling and NYHA improvement. Follow-up for clinical endpoints will be 12 months; with echocardiographic follow-up at 6 months. Clinical endpoints are subject to adjudication committee assessment. Core-labs exist to assess electrocardiographic, echocardiographic and CMR-data.
- Being tested
- Cardiac resynchronization therapy
- Keywords
- cardiac resynchronization therapy, non-LBBB, QRS area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapyDevice
Biventricular pacing according to current standards.
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT response score will assess patient improvement including all-cause mortality, heart failure hospitalization, LVESVi reduction, and NYHA class improvement
Hierarchical endpoint based upon the concepts presented by Packer (Packer, Circulation 2016)
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 posted9 Oct 2019
- Study start26 Aug 2019
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Resynchronization Therapy, Non-LBBB, QRS AreaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Kevin Vernooy, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120909
- Sponsor's protocol ID
- 2018-0863
- Acronym
- MARC-2
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Stipdonk AMW, Ter Horst I, Kloosterman M, Engels EB, Rienstra M, Crijns HJGM, Vos MA, van Gelder IC, Prinzen FW, Meine M, Maass AH, Vernooy K. QRS Area Is a Strong Determinant of Outcome in Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Dec;11(12):e006497. doi: 10.1161/CIRCEP.118.006497.
PubMed 30541356
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB
- ClinicalTrials.gov ID
- NCT04120909
- Acronym / sponsor ID
- MARC-2 / 2018-0863
- Keywords
- cardiac resynchronization therapy, non-LBBB, QRS area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 9 Oct 2019 (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 purpose of the MARC-2 study is to investigate the relation of the QRS area, determined by vectorcardiography, and response to Cardiac Resynchronization Therapy (CRT) in patients with a wide QRS complex and without a typical left bundle branch block; the interrelationship as well as the potential predictive power of this biomarker, as well as other clinical biomarkers on a hierarchal composite endpoint (death, heart failure hospitalizations, heart failure complaints and cardiac function) will be evaluated.
The main biomarker that is studied is the QRS area, but also other electrocardiographic, echocardiographic markers, blood markers and clinical markers will be studied.
Detailed description
For the purpose described in the brief summary, the MARC-2 study investigators have set an aim of including 800 patients in 2 inclusion years, in 30 centres accross Europe and Israel. Inclusion will be general patients indicated for (de novo or upgrade) implantation a (Medtronic) CRT-pacemaker or -ICD, as according to current ESC heart failure guidelines. Exclusion criteria are, age below 18 years, (planning) childbearing, baseline > 5% RV-pacing, listing for transplantation or inotropic dependency, structural heart disease for which invasive therapy is pending, or inability/unwillingness to sign written informed consent. All QRS morphologies, with duration >/= 130ms are included because multiple LBBB definitions exist and excluding patients on one definition will leave room for questions about the definitions used. (Bio)markers that are collected are electrocardiographic/vectorcardiographic/echocardiographic/blood-/CMR/ and device-based parameters that have shown prior association to outcomes in CRT, with special attention to vectorcardiographic QRS area. The primary endpoint will be a hierarchal (Packer) score of collected heart failure related endpoints including death/LVAD/cardiac transpland/heart failure hospitalizations/echocardiographic remodelling and NYHA improvement. Follow-up for clinical endpoints will be 12 months; with echocardiographic follow-up at 6 months. Clinical endpoints are subject to adjudication committee assessment. Core-labs exist to assess electrocardiographic, echocardiographic and CMR-data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study group to be recruited will consist of heart failure patients (NYHA I-IV), male and female, with a reduced left ventricular ejection fraction (LVEF</=35%) and ventricular dyssynchrony (QRS>/=130ms) as measured prior to implantation of a CRT device. Each study subject receives a CRT device with a class I or II indication according to the current CRT ESC/AHA guidelines.
Key inclusion criteria (8 listed)
- Subject is scheduled to be implanted with a CRT-pacemaker or CRT-defibrillator
- Subject has NYHA class I, II, III or ambulant IV
- Subject has LV dysfunction (LVEF</=35%)
- Subject is in sinus rhythm on an ECG less than 45 days before CRT implantation
- Intrinsic QRS duration is >/=130ms (of either QRS morphology) within 30 days prior to CRT device implantation
Key exclusion criteria (14 listed)
- Subject has a pacemaker/ICD with >5% RV pacing.
- Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
- Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
- Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
- Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next 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 |
|---|---|---|
| Cardiac resynchronization therapyBiventricular pacing according to current standards. | Device | – |
Primary outcome
CRT response score will assess patient improvement including all-cause mortality, heart failure hospitalization, LVESVi reduction, and NYHA class improvement
Time frame: 12 months
Hierarchical endpoint based upon the concepts presented by Packer (Packer, Circulation 2016)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Results publication: PubMed 30541356van Stipdonk AMW, Ter Horst I, Kloosterman M, Engels EB, Rienstra M, Crijns HJGM, Vos MA, van Gelder IC, Prinzen FW, Meine M, Maass AH, Vernooy K. QRS Area Is a Strong Determinant of Outcome in Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Dec;11(12):e006497. doi: 10.1161/CIRCEP.118.006497.
- Individual participant dataSharing planned: No
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.
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, Non-LBBB, QRS Area, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Oct 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Vernooy, dr. (+31(0)433877095, kevin.vernooy@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT response score will assess patient improvement including all-cause mortality, heart failure hospitalization, LVESVi reduction, and NYHA class improvement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120909, which also lists 1 linked publication.
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 9 Oct 2019.