NCT05791344

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

March 16, 2023

Last Update Submit

June 1, 2025

Conditions

Transcatheter Aortic Valve ReplacementConduction Disturbance

Outcome Measures

Primary Outcomes (1)

  • Identifying ECG changes during the TAVR procedure

    Identifying intra-procedural ECG changes (such as prolongation of the PR interval or QRS or changes in QRS axis) that may be associated with post TAVR persistent conduction disturbances (AVB or LBBB) at discharge. LBBB).

    14 days

Secondary Outcomes (2)

  • Identifying predictors of conduction disturbances (AVB or LBBB) after TAVR

    30 days

  • Evaluating rates of conduction disturbances (AVB or LBBB) after TAVR

    30 days

Study Arms (1)

ECG Monitoring -TAVR patients

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Device: ECG monitoring

Interventions

ECG monitoringDEVICE

Intra-procedural ECG changes during TAVR

Also known as: Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
ECG Monitoring -TAVR patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a diagnosis of severe aortic stenosis (AS) undergoing TAVR with a commercially available valve, who meet the inclusion and exclusion criteria, will be eligible for participation in this study.

You may qualify if:

  • Subject must be ≥ 18 years of age.
  • Patient with severe symptomatic aortic stenosis (AS) undergoing TAVR with an FDA-approved device. Patients will receive standard-of-care treatment for TAVR, with the exception of the use of a 12-lead ECG monitor during the TAVR procedure (as opposed to 6-lead ECG) and the continuous monitoring by 3-lead ECG Holter for two weeks post-procedure.
  • The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB).
  • Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.

You may not qualify if:

  • Patient with any implanted or have an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
  • Any contraindication to the TAVR procedure according to the instructions for use.
  • Subject is less than the legal age of consent, legally incompetent, or otherwise unable to be consented for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Electrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Shmuel Chen, MD, PhD

    The Weill Cornell Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 30, 2023

Study Start

June 21, 2023

Primary Completion

July 23, 2024

Study Completion

December 31, 2024

Last Updated

June 4, 2025

Record last verified: 2025-06

Locations

US(1)