Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Conduction system pacing Pacing the His-Purkinje system. Crossover to biventricular pacing was 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. |
Device: Conduction system pacing
Lead placed in the His-Purkinje system in order to achieve QRS shortening.
|
| Active Comparator: Biventricular pacing Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals. 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. |
Device: Biventricular pacing
Lead is placed in a tributary of the coronary sinus.
|
Outcome Measures
Primary Outcome Measures
- Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points. [12 months]
Non inferiority margin 10%.
Secondary Outcome Measures
- Change in left ventricular ejection fraction. [6 months; 12 months]
Non inferiority margin 2.5%
- Change in left ventricular end-systolic volume. [6 months; 12 months]
Non inferiority margin 3%
- Echocardiographic response (>=15% decrease in left ventricular end-systolic volume). [6 months; 12 months]
Non inferiority margin 10%
- Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint) [6 months; 12 months]
Non inferiority margin 10%
- QRS shortening [Post-implantation (Electrophysiology Lab)]
Non inferiority margin 12ms
- Correction of septal flash [15 days; 6 months; 12 months]
Non inferiority margin 0.5mm
- Change in NYHA functional class [6 months; 12 months]
NYHA functional class I, II, III, IV.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lluís Mont | Barcelona | Spain |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
- Study Director: Lluís Mont, MD, PhD, Hospital Clinic of Barcelona
- Principal Investigator: Jose M Tolosana, MD, PhD, Hospital Clinic of Barcelona
- Principal Investigator: Margarida Pujol Lopez, MD, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CONSYST-CRT.