Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.
NCT05187611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-07-10
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.
Conditions
- Resynchronization Therapy
- Conduction System Pacing
Interventions
- 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.
Sponsors & Collaborators
-
Hospital Clinic of Barcelona
lead OTHER
Principal Investigators
-
Lluís Mont, MD, PhD · Hospital Clinic of Barcelona
-
Jose M Tolosana, MD, PhD · Hospital Clinic of Barcelona
-
Margarida Pujol Lopez, MD · Hospital Clinic of Barcelona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-17
- Primary Completion
- 2024-07-15
- Completion
- 2025-04-01
- FDA Device
- Yes
Countries
- Spain
Study Locations
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