REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)

Launched by INOVA HEALTH CARE SERVICES · Dec 7, 2022

Keywords

ClinConnect Summary

The REINVENT-CRT trial is studying whether a special heart device called a CRT (Cardiac Resynchronization Therapy) pacing device can help improve heart function and symptoms in patients with heart failure. This trial specifically focuses on patients who have a certain type of heart rhythm problem called Left Bundle-Branch Block (LBBB) and a heart function measurement known as Left Ventricular Ejection Fraction (LVEF) greater than 35%. The goal is to see if this device can make patients feel better and help their hearts work more effectively.

To be eligible for this trial, participants need to be at least 18 years old and have specific heart-related symptoms or conditions. This includes having LBBB, being in certain stages of heart failure, and being on a stable heart failure medication plan. During the study, participants will have to undergo some tests and follow certain guidelines, such as using effective birth control if they are women of childbearing age. If you decide to take part, you will receive close monitoring and support throughout the study to help ensure your safety and well-being.

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