Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conduction system pacing, Biventricular pacing.
- Who it may be relevant to
- Registry conditions: Cardiac Resynchronization Therapy, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Overview
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.
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 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.
Interventions
- Procedure Conduction system pacing
Conduction system pacing implant as a Resynchronization therapy. - Procedure Biventricular pacing
Biventricular pacing implant
Primary outcome measures
- Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization. [Time frame: 1 year]
Secondary outcome measures (12)
- Change in left ventricular ejection fraction. [Time frame: 6 months; 1 year]
- Change in left ventricular end-systolic volume. [Time frame: 6 months; 1 year]
- Echocardiographic response. [Time frame: 6 months; 1 year]
- Change in NYHA functional class. [Time frame: 6 months; 1 year]
- QRS shortening. [Time frame: Immediately after the intervention]
- Correction of septal flash. [Time frame: 15 days; 6 months; 1 year]
- Correction of auriculoventricular dyssynchrony. [Time frame: 15 days; 6 months; 1 year]
- Correction of interventricular dyssynchrony. [Time frame: 15 days; 6 months; 1 year]
- Change in global longitudinal strain (GLS). [Time frame: 15 days; 6 months; 1 year]
- Description of baseline predictors of response to conduction system pacing and biventricular pacing. Cardiac fibrosis quantification. [Time frame: Baseline (pre intervention).]
- Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Left ventricular activation time (LVAT), ms. [Time frame: Baseline (pre intervention). And immediately after the intervention]
- Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Ventricular electrical uncoupling (VEU). [Time frame: Baseline (pre intervention). And immediately after the intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT06105580 · CONSYST-CRT II