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

Heart Failure Clinical Trial

— CONSYST-CRT II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105580
• Other study ID #: CONSYST-CRT II
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: November 2027

Study information

• Verified date: December 2023
• Source: Hospital Clinic of Barcelona
• Contact: Jose Mª Tolosana, MD, PhD
• Phone: 93 2271778 (2094)
• Email: tolosana[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Procedure:
• Conduction system pacing
Conduction system pacing implant as a Resynchronization therapy.
• Biventricular pacing
Biventricular pacing implant

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization.	Clinical follow-up at 12 months	1 year
Secondary	Change in left ventricular ejection fraction.	Left ventricular ejection fraction measured with Simpson method with echocardiography.	6 months; 1 year
Secondary	Change in left ventricular end-systolic volume.	Left ventricular volumes measured with echocardiography. Simpson rule from 2- and 4-chamber apical views.	6 months; 1 year
Secondary	Echocardiographic response.	>=15% decrease in left ventricular end-systolic volume	6 months; 1 year
Secondary	Change in NYHA functional class.	NYHA functional class I, II, III, or IV	6 months; 1 year
Secondary	QRS shortening.	QRS duration (milliseconds). QRS onset measured from fast deflection and from spike.	Immediately after the intervention
Secondary	Correction of septal flash.	Fast inward-outward movement of the interventricular septum in early systole. Using M-mode in parasternal short and long-axis views, septal flash was quantified (in millimeters) as the highest amplitude of the early inward motion measured from the resting position prior to the onset of septal contraction. The pair of septal flash measures (baseline and final) was obtained at the axis with the highest baseline SF.	15 days; 6 months; 1 year
Secondary	Correction of auriculoventricular dyssynchrony.	Left ventricular filling time. The left ventricular filling time was measured from the onset of the E-wave to the end of the A-wave, and the R-R interval was measured to calculate the percentage of filling time relative to the cardiac cycle (LV filling time/RR, %).	15 days; 6 months; 1 year
Secondary	Correction of interventricular dyssynchrony.	Quantified using pulsed Doppler and calculated as the time difference between QRS onset and the onset of the flow wave in the right and left outflow tracts.	15 days; 6 months; 1 year
Secondary	Change in global longitudinal strain (GLS).	Strain myocardial deformation of the left ventricle was quantified offline from 2-dimensional echocardiography using speckle tracking (2Dstrain, Echo Pac, version 202.41.0, GE Healthcare Milwaukee, WI). The long-axis cine images (2-, 3-, and 4-chamber views), were used to determine GLS.	15 days; 6 months; 1 year
Secondary	Description of baseline predictors of response to conduction system pacing and biventricular pacing. Cardiac fibrosis quantification.	Cardiac fibrosis quantification (grams of fibrosis)	Baseline (pre intervention).
Secondary	Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Left ventricular activation time (LVAT), ms.	Left ventricular activation time (LVAT), ms.	Baseline (pre intervention). And immediately after the intervention
Secondary	Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Ventricular electrical uncoupling (VEU).	Ventricular electrical uncoupling (VEU) = mean left ventricular activation time - mean right ventricular activation time, ms	Baseline (pre intervention). And immediately after the intervention
Secondary	Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Left ventricular dyssynchrony index (LVDI).	Left ventricular dyssynchrony index (LVDI): standard deviation of individual activations recorded from the left ventricle.	Baseline (pre intervention). And immediately after the intervention
Secondary	Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Conduction velocity (cm/s).	Conduction velocity (cm/s).	Baseline (pre intervention). And immediately after the intervention