REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Launched by INOVA HEALTH CARE SERVICES · Dec 7, 2022
Trial Information
Current as of January 13, 2025
Completed
Keywords
ClinConnect Summary
This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (\>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
- • Stated willingness to comply with all study procedures and availability for the duration of the study
- • Male or female aged ≥18 years
- • Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads.
- • NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic
- • LVEF \>35% by clinically obtained echocardiogram overread by the study core-lab
- • Demonstration of adequate echocardiographic images to allow for assessment of endpoints
- • On a stable guideline directed HF medical regimen
- • For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- • Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
- Exclusion Criteria:
- • Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study
- • Treatment with another investigational drug or other intervention within 3 months
- • Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months
- • Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)
- • Significant structural heart \[including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)\]
- • Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg)
- • Oxygen dependent chronic lung disease
- • Prolonged episodes of AF (\>3 days or an AF burden \>10%) within the preceding 3 months
- • Presence of cardiac pacemaker or implantable cardioverter defibrillator
- • Prior mechanical tricuspid valve replacement
- • Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus
- • Known allergic reactions to components of the pacemaker or leads
- • Febrile illness within 3 days of trial enrollment
- • Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- • Control Participant Exclusion Criteria: same
Trial Officials
Brett Atwater, MD
Principal Investigator
Inova Health Care Services
About Inova Health Care Services
Inova Health Care Services is a leading healthcare organization dedicated to providing high-quality, patient-centered care across a comprehensive range of medical specialties. With a commitment to advancing clinical research and innovation, Inova actively sponsors and conducts clinical trials aimed at improving health outcomes and enhancing treatment options for patients. The organization combines state-of-the-art facilities, a skilled team of medical professionals, and a robust research infrastructure to facilitate groundbreaking studies that address pressing health challenges. Through its dedication to excellence in clinical research, Inova Health Care Services strives to contribute to the evolving landscape of healthcare and improve the lives of individuals in the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Falls Church, Virginia, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Similar Trials