Clinical trial NCT05187611: Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.
Official title: Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Resynchronization Therapy
Conduction System Pacing
Keywords: Resynchronization Therapy
Biventricular pacing
Conduction system pacing
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
Primary purpose: TREATMENT

Brief 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.

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 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.
timeFrame: 12 months
Secondary outcomes:
measure: Change in left ventricular ejection fraction.
timeFrame: 6 months; 12 months
measure: Change in left ventricular end-systolic volume.
timeFrame: 6 months; 12 months
measure: Echocardiographic response (>=15% decrease in left ventricular end-systolic volume).
timeFrame: 6 months; 12 months
measure: Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint)
timeFrame: 6 months; 12 months
measure: QRS shortening
timeFrame: Post-implantation (Electrophysiology Lab)
measure: Correction of septal flash
timeFrame: 15 days; 6 months; 12 months
measure: Change in NYHA functional class
timeFrame: 6 months; 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Lluís Mont
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Lluís Mont, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Jose M Tolosana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Margarida Pujol Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: