NCT06105580: CONSYST-CRT II

Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant

Recruiting now NA Last updated 30 March 2026

What this trial tests

NA trial testing Conduction system pacing in Cardiac Resynchronization Therapy in 320 participants. Currently enrolling.

Timeline

27 November 2023

Primary endpoint
1 November 2027

1 January 2028

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	320
Start date	27 November 2023
Primary completion	1 November 2027
Estimated completion	1 January 2028
Sites	1 location across Spain

Drugs / interventions tested

• Conduction system pacing
• Biventricular pacing

Conditions studied

• Cardiac Resynchronization Therapy — all drugs for Cardiac Resynchronization Therapy →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with Cardiac Resynchronization Therapy or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization.
  Time frame: 1 year
  Clinical follow-up at 12 months

Sponsor's own description

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial).

Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Is Conduction System Pacing a Valuable Alternative to Biventricular Pacing for Cardiac Resynchronization Therapy?
   Castagno D, Zanon F, Pastore G, De Ferrari GM, et al · · 2024 · cited 2× · PMID 38786966 · DOI 10.3390/jcdd11050144