Status:
UNKNOWN
MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Cardiac Resynchronization Therapy, Non-LBBB, QRS Area
Eligibility:
All Genders
18+ years
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 co...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04120909
Start Date
August 26 2019
End Date
August 1 2022
Last Update
October 9 2019
Active Locations (1)
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1
Maastricht UMC+
Maastricht, Netherlands