Conduction System Stimulation to Avoid Left Ventricle Dysfunction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrioventricular Block, Second and Third Degree
- Sponsor
- Parc de Salut Mar
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Delta-LVEF at 6 months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a single-center, prospective, randomized, parallel, controlled study, comparing mid-term outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in accordance with the Declaration of Helsinki. All patients signed informed consent and were implanted between September 2019 until December 2022 in a 1:1 randomized fashion to conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural antibiotic infusion. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up, including demographic and clinical characteristics, physical examination, twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination. Patients also have a transthoracic echography before the procedure and at 6 months follow-up. At 6 months echocardiographic and clinical data will be compared.
Investigators
Ermengol Vallès
Principal investigator
Parc de Salut Mar
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Delta-LVEF at 6 months
Time Frame: 6 months
Change in LVEF in each group at 6 months vs baseline LVEF
Secondary Outcomes
- Delta-LVEDD at 6 months(6 months)
- Delta-New York Heart Association (NYHA) class at 6 months(6 months)
- Delta-NTProBNP at 6 months(6 months)
- New onset Atrial fibrillation(6 months)
- Delta-MLWHFQ (Minnesota score) at 6 months(6 months)
- Readmissions due to heart failure(6 months)
- Mortality(6 months)