Status:
COMPLETED
Markers and Response to Cardiac Resynchronization Therapy
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Center for Translational Molecular Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate: the relation of a set of (bio)markers and response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the potential predictive po...
Detailed Description
Title MARC (Markers And Response to CRT) - Prospective CRT study Sponsor and study management The MARC study is being sponsored by all participants of the COHFAR project as being defined in the COH...
Eligibility Criteria
Inclusion
- Subject is indicated for CRT-D device according to current applicable ESC/AHA guidelines
- Subject has NYHA class II or III
- Subject has stable sinus rhythm (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion) No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
- Intrinsic QRS-width ≥ 130 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class II
- Intrinsic QRS-width ≥ 120 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class III
- 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 enrollment
- Subject is willing to sign informed consent form
- Subject is 18 years or older
Exclusion
- Subject is upgraded from a bradycardia pacemaker to CRT-D
- Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
- Subject has permanent atrial fibrillation/ flutter or tachycardia.
- Subject experienced recent myocardial infarction (MI), 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 chronic renal dialysis
- Subject has severe renal disease (defined as Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2)
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
- Subject has RBBB
- 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 :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01519908
Start Date
February 1 2012
End Date
December 1 2014
Last Update
April 18 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Medical Center
Amsterdam, Netherlands
2
Free University
Amsterdam, Netherlands
3
Medisch Spectrum Twente
Enschede, Netherlands
4
University Medical Center Groningen
Groningen, Netherlands