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

NCT ID: NCT06105580

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2027-11-30

Brief 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.

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 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.

Conditions

Cardiac Resynchronization Therapy; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conduction system pacing

Pacing the His-Purkinje system.

Crossover to biventricular pacing allowed in case of failed conduction system pacing: failed His bundle pacing and failed Left bundle branch pacing (high thresholds (>3.5V / 1ms); no left bundle branch pacing criteria; no left bundle branch correction).

Electrocardiographic optimization allowed in order to obtain the narrowest QRS.

Group Type: EXPERIMENTAL

Conduction system pacing

Intervention Type: PROCEDURE

Conduction system pacing implant as a Resynchronization therapy.

Biventricular pacing

Pacing from the right ventricular and coronary sinus lead. Electrocardiographic optimization with fusion-optimized intervals (FOI).

Crossover from biventricular pacing to conduction system pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation.

Group Type: ACTIVE_COMPARATOR

Biventricular pacing

Intervention Type: PROCEDURE

Biventricular pacing implant

Interventions

Conduction system pacing

Conduction system pacing implant as a Resynchronization therapy.

Intervention Type: PROCEDURE

Biventricular pacing

Biventricular pacing implant

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient must indicate acceptance to participate in the study by signing an informed consent document.
• Patient must be ≥ 18 years of age.
• Left bundle branch block, QRS ≥130 and LVEF <=35%. No indication of stimulation for AV block.
• Non-left bundle branch block, QRS ≥150 and LVEF <=35%.
• Resynchronization therapy indication for ventricular dysfunction (LVEF <40%) and indication 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 Criteria

• Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
• Pregnancy.
• Participating currently in a clinical investigation that includes an active treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Josep Lluis Mont Girbau

Head of Arrhythmia Research.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Mª Tolosana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer

Margarida Pujol López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer

Lluís Mont, MD, PhD

Role: STUDY_CHAIR

Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer

Locations

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jose Mª Tolosana, MD, PhD

Role: CONTACT

tolosana@clinic.cat

93 2271778 (2094)

Margarida Pujol López, MD

Role: CONTACT

mapujol@clinic.cat

93 2271778 (2094)

Facility Contacts

JM Tolosana, MD, PhD

Role: primary

tolosana@clinic.cat

M Pujol Lopez, MD

Role: backup

Other Identifiers

CONSYST-CRT II

Identifier Type: -

Identifier Source: org_study_id