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Intra-procedural ECG Changes During TAVR

NCT05791344 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-06-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block (AVB) (1st, 2nd, or 3rd degree), or new-onset left bundle branch block (LBBB) that may occur during the procedure. Eligible patients enrolled in this study will be monitored with an FDA-approved ECG Holter system during TAVR, to assess intra-procedural changes. This will be a small-scale, early feasibility study performed to inform a future, larger-scale prospective investigation.

Conditions

  • Transcatheter Aortic Valve Replacement
  • Conduction Disturbance

Interventions

DEVICE

ECG monitoring

Intra-procedural ECG changes during TAVR

Sponsors & Collaborators

  • Cara Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Shmuel Chen, MD, PhD · The Weill Cornell Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2024-07-23
Completion
2024-12-31

Countries

  • United States

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 NCT05791344 on ClinicalTrials.gov