Intra-procedural ECG Changes During TAVR

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement; Conduction Disturbance
• Intervention / Treatment: Device: ECG monitoring

Detailed Description

Transcatheter aortic valve replacement (TAVR) has become a well-established alternative to surgical intervention for patients with severe symptomatic aortic stenosis (AS) (1-4). The rates of most TAVR complications have declined over time due to the improvement of operator experience and technological advancement; however, conduction abnormalities continue to persist (5). New-onset left bundle branch block (LBBB) and atrioventricular nodal block (AVB) are among the most common conduction disturbances (6). Additionally, there is an increased incidence of delayed (after discharge) HAVB (2nd-degree AVB Mobitz type 2 or 3rd-degree AVB) in patients with preexisting (pre-TAVR) right bundle branch block (RBBB) and new-onset LBBB post-TAVR, 13.2%, and 8.5%, respectively (7).

Currently, conduction disturbances post-TAVR are assessed via post-procedural ECG, and physicians performing TAVR are not provided feedback in real time. The use of intraprocedural ECG could provide insight into the status of the heart's conduction system during TAVR and prevent irreversible injury, requiring post-procedural monitoring at intensive cardiac care unit (usually with a temporary pacemaker in situ) or even permanent pacemaker implantation. Furthermore, given the increased incidence of HAVB after valve replacement in patients with preexisting RBBB and new-onset LBBB, continued post-procedural ECG monitoring in this particular subset of patients may provide more information on the progression of conduction disturbances after TAVR.

This will be a small-scale, early feasibility study evaluating intra-procedural ECG changes, such as AVB (1st, 2nd, or 3rd degree), or new-onset LBBB, in patients undergoing TAVR, to inform a future, larger scale, prospective investigation.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Shmuel Chen, MD, PhD; Phone Number: 001-347 319 6106; Email: shc9182@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • The Weill Cornell Medicine
      • Contact: Shmuel Chen, MD PhD; Phone Number: 347-319-6106; Email: shc9182@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

1. Subject must be ≥ 18 years of age.
2. 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.
3. 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).
4. Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.

Exclusion Criteria:

1. 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.
2. Any contraindication to the TAVR procedure according to the instructions for use.
3. Subject is less than the legal age of consent, legally incompetent, or otherwise unable to be consented for participation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECG Monitoring -TAVR patients; Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure	Device: ECG monitoring; Intra-procedural ECG changes during TAVR; Other Names: Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying predictors of conduction disturbances (AVB or LBBB) after TAVR	Identifying predictors on intra-procedural ECG for late-onset (after discharge) high degree AVB.	30 days
Evaluating rates of conduction disturbances (AVB or LBBB) after TAVR	Evaluating rates of late-onset (after discharge) high-degree AVB (HAVB = second-degree AVB Mobitz type 2 or third-degree AVB) after TAVR.	30 days

Collaborators and Investigators

• Sponsor: Cara Medical Ltd
• Investigators: Principal Investigator: Shmuel Chen, MD, PhD, The Weill Cornell Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Estimated): February 6, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 22-07025053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No