Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 improve at 12 months in a combined clinical endpoint.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Lluís Mont, MD, PhD
lmont@clinic.cat
93 2271778 Ext. 2094
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 48
Treatments
Experimental: Conduction system pacing
Lead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing.~Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing.
Active_comparator: Right ventricular pacing
Lead placed in the right ventricle (conventional pacing).
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona