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

NCT04120909 | Unknown DMC

• 1 other identifier: 2018-0863
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy, Non-LBBB, QRS Area

Keywords

cardiac resynchronization therapy, non-LBBB, QRS area

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Interventions

Cardiac resynchronization therapy DEVICE

Biventricular pacing according to current standards.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Maastricht UMC+

Maastricht, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 30541356 RESULT

MeSH Terms

Interventions

Cardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Kevin Vernooy, dr.

CONTACT

+31(0)433877095; kevin.vernooy@mumc.nl

Mohammed Ghossein, drs.

CONTACT

+31(0)433884520; mohammed.ghossein@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Kevin Vernooy

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: August 26, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)