MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB

NCT ID: NCT04120909

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2022-08-31

Brief 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 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.

Conditions

Cardiac Resynchronization Therapy, Non-LBBB, QRS Area

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac resynchronization therapy

Biventricular pacing according to current standards.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kevin Vernooy

dr. Kevin Vernooy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maastricht UMC+

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Kevin Vernooy, dr.

Role: CONTACT

kevin.vernooy@mumc.nl

+31(0)433877095

Mohammed Ghossein, drs.

Role: CONTACT

mohammed.ghossein@mumc.nl

+31(0)433884520

Facility Contacts

Mohammed Ghossein, drs.

Role: primary

mohammed.ghossein@mumc.nl

+31(0)433884520

References

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.

Reference Type: RESULT

PMID: 30541356 (View on PubMed)

Other Identifiers

2018-0863

Identifier Type: -

Identifier Source: org_study_id