Status:
RECRUITING
Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Transcatheter Aortic Valve Implantation
Physiological Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who impro...
Detailed Description
There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to eluci...
Eligibility Criteria
Inclusion
- Successful implantation of TAVI according to VARC-3 criteria.
- Indication of cardiac pacing due to AV block according to ESC Guidelines.
- LVEF\> 50%.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Exclusion
- Ventricular dysfunction: LVEF \<50%.
- Transapical TAVI.
- Participating currently in a clinical investigation that includes an active treatment.
- Patients with left bundle branch block but without indication of pacing (AV block).
- Life expectancy \<12 months.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06197503
Start Date
November 30 2023
End Date
December 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036