NCT05652218

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	LB-CRT	LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
DEVICE	BIV-CRT	BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).

Timeline

• Start date: 2023-02-26
• Primary completion: 2026-02-28
• Completion: 2026-03-31
• First posted: 2022-12-15
• Last updated: 2026-01-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study