NCT05187611

Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.

Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement \<5 points.

Detailed description

To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy. This study will randomize 130 patients to a strategy of biventricular pacing versus conduction system pacing. CONSYST-CRT study will analyze the following parameters in the 2 groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic asynchrony (septal flash). Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year. The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)

Conditions

• Resynchronization Therapy
• Conduction System Pacing

Interventions

Type	Name	Description
DEVICE	Conduction system pacing	Lead placed in the His-Purkinje system in order to achieve QRS shortening.
DEVICE	Biventricular pacing	Lead is placed in a tributary of the coronary sinus.

Timeline

• Start date: 2022-01-17
• Primary completion: 2024-07-15
• Completion: 2025-04-01
• First posted: 2022-01-12
• Last updated: 2025-07-10

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study