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

Last updated: March 14, 2025
Sponsor: Hospital Clinic of Barcelona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

Biventricular pacing

Conduction system pacing

Clinical Study ID

NCT06105580
CONSYST-CRT II
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient must indicate acceptance to participate in the study by signing an informedconsent document.

  • Patient must be ≥ 18 years of age.

  • Left bundle branch block, QRS ≥130 and LVEF <=35%. No indication of stimulation forAV block.

  • Non-left bundle branch block, QRS ≥150 and LVEF <=35%.

  • Resynchronization therapy indication for ventricular dysfunction (LVEF <40%) andindication of cardiac pacing for AV block.

  • LVEF <=35% in NYHA class III or IV, atrial fibrillation and intrinsic QRS >=130 ms,provided a strategy to ensure biventricular capture is in place.

Exclusion

Exclusion Criteria:

  • Myocardial infarction, unstable angina or cardiac revascularization during theprevious 3 months.

  • Pregnancy.

  • Participating currently in a clinical investigation that includes an activetreatment.

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Biventricular pacing
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
November 30, 2027

Study 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 320 patients to a strategy of biventricular pacing versus conduction system pacing.

CONSYST-CRT II study will analyze a clinical endpoint as primary endpoint and the following parameters in both 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 dyssynchrony (atrioventricular, interventricular, intraventricular) and global longitudinal strain.

As a secondary endpoint, baseline predictors of response to conduction system pacing and biventricular pacing according to cardiac magnetic ressonance and electrocardiographic imaging will be studied.

Clinical, electrocardiographic, echocardiographic follow-up will be performed during 12 months.

Connect with a study center

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

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