Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction system pacing | Experimental | 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. |
|
| Biventricular pacing | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction system pacing | Device | Lead placed in the His-Purkinje system in order to achieve QRS shortening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction. | Non inferiority margin 2.5% | 6 months; 12 months |
| Change in left ventricular end-systolic volume. | Non inferiority margin 3% |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LluÃs Mont, MD, PhD | Hospital Clinic of Barcelona | Study Director |
| Jose M Tolosana, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Margarida Pujol Lopez, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LluÃs Mont | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40372330 | Derived | Pujol-Lopez M, Graterol FR, Borras R, Garcia-Ribas C, Guichard JB, Regany-Closa M, Jimenez-Arjona R, Niebla M, Poza M, Carro E, Castel MA, Arbelo E, Porta-Sanchez A, Sitges M, Roca-Luque I, Doltra A, Guasch E, Tolosana JM, Mont L. Clinical Response to Resynchronization Therapy: Conduction System Pacing vs Biventricular Pacing: The CONSYST-CRT Trial. JACC Clin Electrophysiol. 2025 Aug;11(8):1820-1831. doi: 10.1016/j.jacep.2025.03.024. Epub 2025 May 14. |
Not provided
Not provided
Not provided
The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
Not provided
Not provided
Not provided
| Biventricular pacing | Device | Lead is placed in a tributary of the coronary sinus. |
|
| 6 months; 12 months |
| Echocardiographic response (>=15% decrease in left ventricular end-systolic volume). | Non inferiority margin 10% | 6 months; 12 months |
| Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint) | Non inferiority margin 10% | 6 months; 12 months |
| QRS shortening | Non inferiority margin 12ms | Post-implantation (Electrophysiology Lab) |
| Correction of septal flash | Non inferiority margin 0.5mm | 15 days; 6 months; 12 months |
| Change in NYHA functional class | NYHA functional class I, II, III, IV. | 6 months; 12 months |
| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
Not provided
Not provided