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

NCT04482816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Physiological pacing

Pacing of the his bundle or the left bundle branch

DEVICE

Right ventricular pacing

Conventional pacing; right ventricular pacing

Sponsors & Collaborators

  • Josep Lluis Mont Girbau

    lead OTHER

Principal Investigators

  • José M Tolosana, MD, PhD · Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  • Margarida Pujol Lopez, MD · Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  • Lluís Mont, MD, PhD · Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  • Eduard Guasch, MD, PhD · Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2023-06-30
Completion
2023-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482816 on ClinicalTrials.gov