REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (… (NCT05652218) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
United States21 participantsStarted 2023-02-26
Plain-language summary
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF \> 35%, and LBBB.
Who can participate
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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 wi…
What they're measuring
1
Change in myocardial performance index (MPI) as compared to Baseline
Timeframe: Baseline and 3 month treatment period after each pacing mode