Clinical trial · Interventional
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block). After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrioventricular Block, Second and Third Degree | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Pacemaker-Induced Cardiomyopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pacemaker implant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CSP (Conduction system pacing)
- description
- Patients with pacemaker implanted with conduction system pacing.
- interventionNames
- Device: Pacemaker implant
- type
- ACTIVE_COMPARATOR
- label
- RVAP (Right ventricular apical pacing)
- description
- Patients with pacemaker implanted with right ventricular apical pacing.
- interventionNames
- Device: Pacemaker implant
Primary outcomes (1)
- measure
- Delta-LVEF at 6 months
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Age of 18 years or more 2. Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography. 3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>50%). 4. Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up. Exclusion criteria: 1. Indication for implantable cardioverter defibrillator device. 2. Patients with previous LVD and a recovered LVEF 3. History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization 4. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
References
Publications (1)
- DERIVEDGonzalez-Matos CE, Rodriguez-Queralto O, Zaraket F, Jimenez J, Casteigt B, Valles E. Conduction System Stimulation to Avoid Left Ventricle Dysfunction. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012473. doi: 10.1161/CIRCEP.123.012473. Epub 2024 Jan 29. PMID 38284238