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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Jose Mª Tolosana, MD, PhD
tolosana@clinic.cat
93 2271778 (2094)
Backup
Margarida Pujol López, MD
mapujol@clinic.cat
93 2271778 (2094)
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2027-11
Participants
Target number of participants: 320
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona
Collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer

This content was sourced from clinicaltrials.gov