Intra-procedural ECG Changes During TAVR

NCT ID: NCT05791344

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-21
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Transcatheter Aortic Valve Replacement; Conduction Disturbance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

ECG Monitoring -TAVR patients

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

ECG monitoring

Intervention Type: DEVICE

Intra-procedural ECG changes during TAVR

Interventions

ECG monitoring

Intra-procedural ECG changes during TAVR

Intervention Type: DEVICE

Other Intervention Names

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cara Medical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shmuel Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Weill Cornell Medicine

Locations

The Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

22-07025053

Identifier Type: -

Identifier Source: org_study_id