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FACT-CRT

Title Factors Associated with Response to Cardiac Resynchronization Therapy in Heart Failure Patients with Non-LBBB ECG Pattern
Therapeutic Area Cardiac Failure, Heart Failure
Principal Investigator Christopher Madias, MD
Min Age 18 Years
Gender Any
Contact Nadia Bokhari
617-636-4276
nbokhari@tuftsmedicalcenter.org

Overview

Heart failure is a harmful disease that is associated with high avoidable moribidity that can be treated with a cardiac resynchronization therapy device (CRT-D). Previous studies have shown links between CRT-D implants and reduced rates of morbidity in patients with heart failure with left bundle branch blockages (LBBB). However, there is limited amounts of evidence for the success of heart failure patients with non-LBBB. This prospective, multi-center study is looking at heart failure patients with non-LBBB that are implanted with CRT-D. 

Study Details

Inclusion Criteria

  • Optimal medical therapy for heart failure as established by current guidelines
  •  Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following: a) New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS ≥150 ms, b) NYHA class III-Iva HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms, c) NYHA class III-Iva HF, LVEF ≤ 35%, and QRS duration 120-149 ms
  • Successful CRT-D generator implant

Exclusion Criteria

  • Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant
  • Unable to obtain the 20-minute ECG prior to CRT-D implant
  • Unable to enroll within 14 days following successful CRT-D generator implant

Study Requirements

Participants will be screened, consented, and enrolled at an initial visit. After being enrolled, participants will have their baseline data collected. At this point, eligible participants will also undergo a pregnancy test. Prior to the CRT-D implant, the participant needs to have had an echocardiogram and a 20 minute electrocardiogram. The electrocardiogram is a research activity that must be done after consent but prior to the CRT-D implant. The baseline data collection is followed by the standard of care CRT-D implantation. There will be remote or in-clinic follow-up visits every 6 months for 48 months. These remote follow-ups include device interrogations and reporting instances of heart failure, death, ventricular tachycardias, and ventricular fibrillations.