Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.

Conduction System Pacing Clinical Trial

— CONSYST-CRT  

Official title:

Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05187611
• Other study ID #: CONSYST-CRT.
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement <5 points.

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 130 patients to a strategy of biventricular pacing versus conduction system pacing. CONSYST-CRT study will analyze the following parameters in the 2 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 asynchrony (septal flash). Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year. The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must indicate their acceptance to participate in the study by signing an informed consent document.
• The 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%.
• Patients with indication of resynchronization therapy for ventricular dysfunction (LVEF <40%) and indication of cardiac pacing for AV block.
• LVEF <=35% in NYHA class III or IV if they are in atrial fibrillation and have 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.

Related Conditions & MeSH terms

• Conduction System Pacing
• Resynchronization Therapy
• Systolic Murmurs

Intervention

Device:
• Conduction system pacing
Lead placed in the His-Purkinje system in order to achieve QRS shortening.
• Biventricular pacing
Lead is placed in a tributary of the coronary sinus.

Locations

Country	Name	City	State
Spain	Lluís Mont	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.	Non inferiority margin 10%.	12 months
Secondary	Change in left ventricular ejection fraction.	Non inferiority margin 2.5%	6 months; 12 months
Secondary	Change in left ventricular end-systolic volume.	Non inferiority margin 3%	6 months; 12 months
Secondary	Echocardiographic response (>=15% decrease in left ventricular end-systolic volume).	Non inferiority margin 10%	6 months; 12 months
Secondary	Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint)	Non inferiority margin 10%	6 months; 12 months
Secondary	QRS shortening	Non inferiority margin 12ms	Post-implantation (Electrophysiology Lab)
Secondary	Correction of septal flash	Non inferiority margin 0.5mm	15 days; 6 months; 12 months
Secondary	Change in NYHA functional class	NYHA functional class I, II, III, IV.	6 months; 12 months