NCT06026683Completed
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
Source: ClinicalTrials.gov · Last updated 3 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 28 Aug 2023
- Start date
- 30 Sept 2019
- Primary completion date
- 2 Oct 2023
- Lead sponsor
- Parc de Salut Mar
- Diseases
- Heart failure
- NCT number
- NCT06026683
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 30 Sept 2019 to the primary completion date, 2 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization
Other illness
- Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
Lab values
- Patients with previous LVD and a recovered LVEF
Other
- Indication for implantable cardioverter defibrillator device.
Who the study is looking for
- Age of 18 years or more
- Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
- Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>50%).
- Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.