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

Left Bundle-Branch Block Clinical Trial

— REINVENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652218
• Other study ID #: U22-04-4739
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Inova Health Care Services
• Contact: Tracy Plummer, BSN
• Phone: 703.776.3567
• Email: tracy.plummer[@]inova.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Failure (HF)
• Left Bundle-Branch Block
• Left Ventricular Ejection Fraction

Intervention

Device:
• LB-CRT
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
• BIV-CRT
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Health System	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial performance index (MPI) as compared to Baseline	Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.	Baseline and 3 month treatment period after each pacing mode