NCT04482816

Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Josep Lluis Mont Girbau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters. Investigators will include 24 patients without ventricular dysfunction (LVEF\> 50%) and with AV block pacing indication after TAVI. Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional). PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12) Clinical, and echocardiographic follow-up will be performed for 1 year.

Conditions

• Transcatheter Aortic Valve Implantation
• Physiological Pacing
• Right Ventricular Pacing
• AV Block

Interventions

Type	Name	Description
DEVICE	Physiological pacing	Pacing of the his bundle or the left bundle branch
DEVICE	Right ventricular pacing	Conventional pacing; right ventricular pacing

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-06-30
• Completion: 2023-10-30
• First posted: 2020-07-23
• Last updated: 2023-12-15

Locations

1 site across 1 country: Spain