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

NCT06105580 | Recruiting

• 1 other identifier: CONSYST-CRT II
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy; Heart Failure

Keywords

left bundle branch pacing; biventricular pacing; cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization.

  Clinical follow-up at 12 months

  1 year

Secondary Outcomes (14)

• Change in left ventricular ejection fraction.

  6 months; 1 year

• Change in left ventricular end-systolic volume.

  6 months; 1 year

• Echocardiographic response.

  6 months; 1 year

• Change in NYHA functional class.

  6 months; 1 year

• QRS shortening.

  Immediately after the intervention

Study Arms (2)

Conduction system pacing

EXPERIMENTAL

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.

Procedure: Conduction system pacing

Biventricular pacing

ACTIVE COMPARATOR

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.

Procedure: Biventricular pacing

Interventions

Conduction system pacing PROCEDURE

Conduction system pacing implant as a Resynchronization therapy.

Conduction system pacing

Biventricular pacing PROCEDURE

Biventricular pacing implant

Biventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• José Mª Tolosana, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Margarida Pujol López, MD

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

  PRINCIPAL INVESTIGATOR

• Lluís Mont, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Jose Mª Tolosana, MD, PhD

CONTACT

93 2271778 (2094); tolosana@clinic.cat

Margarida Pujol López, MD

CONTACT

93 2271778 (2094); mapujol@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Research.

Model Details: The first 130 patients have been recruited in the context of the CONSYST I study (ClinicalTrials.gov Identifier: NCT05187611). It is planned to perform an interim analysis (intermediate analysis) for the primary endpoint in all randomized patients who received intervention. The formal limits of stopping the study will be determined by the limits of futility and effectiveness defined by the rules of sequential stopping using the O'Brien-Fleming method. The interim analysis will be performed with a sample recruitment of 50%. Members of the Data Monitoring Committee, but not any trial investigator, will be informed of the results of the interim analysis. A p of 0.0054 (two-sided alpha) will be required for the interim analysis and 0.049 in the final analysis.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 27, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)