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NCT05652218Active, not recruiting

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

REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
21 (actual)
First submitted
7 Dec 2022
Start date
26 Feb 2023
Primary completion date
28 Feb 2026
Lead sponsor
Inova Health Care Services
NCT number
NCT05652218

What you commit to

  • Study type: Interventional
  • Participants enrolled: 21
  • From 26 Feb 2023 to the primary completion date, 28 Feb 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior mechanical tricuspid valve replacement
  • Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus

Other illness

  • 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
  • Presence of cardiac pacemaker or implantable cardioverter defibrillator
  • Known allergic reactions to components of the pacemaker or leads
  • Febrile illness within 3 days of trial enrollment

Other

  • Prolonged episodes of AF (\>3 days or an AF burden \>10%) within the preceding 3 months
  • 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

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Inova Health System
Coordinator of this site? Confirm its status
Falls ChurchUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.