Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3)...

Area of Science:

• Cardiology
• Medical Devices
• Clinical Trials

Background:

• Cardiac resynchronization therapy (CRT) effectively treats heart failure (HF) with reduced ejection fraction and wide QRS.
• A significant proportion of patients do not respond to standard CRT.
• Optimizing CRT may involve increasing stimulation sites, as explored in smaller studies.

Purpose of the Study:

• To evaluate the clinical benefit of adding a second LV lead in nonresponders to standard biventricular stimulation.
• To assess if increased LV stimulation improves outcomes in heart failure patients.
• The V(3) trial specifically targets nonresponders to optimize CRT efficacy.

Main Methods:

• A multicenter, randomized trial design involving 84 patients across 11 French medical centers.
• Patients are randomized to either an additional LV lead or their current stimulation system.
• Primary endpoint is the HF clinical composite score at 1-year follow-up; secondary endpoints include echocardiographic and clinical changes.

Main Results:

• The study is designed to enroll 84 patients and is expected to complete enrollment within one year.
• The primary outcome measure is the HF clinical composite score after one year.
• Secondary outcome measures include echocardiographic reverse remodeling and clinical measurements.

Conclusions:

• The V(3) trial will determine the clinical benefit of a second LV lead in CRT nonresponders.
• This research addresses the unmet need for improved CRT efficacy in nonresponding heart failure patients.