Clinical trial NCT05791344: Intra-procedural ECG Changes During TAVR
Official title: Intra-procedural ECG Changes During TAVR
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Transcatheter Aortic Valve Replacement
Conduction Disturbance
Lead sponsor: Cara Medical Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Identifying ECG changes during the TAVR procedure
timeFrame: 14 days
Secondary outcomes:
measure: Identifying predictors of conduction disturbances (AVB or LBBB) after TAVR
timeFrame: 30 days
measure: Evaluating rates of conduction disturbances (AVB or LBBB) after TAVR
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: The Weill Cornell Medicine
state: New York
Study officials:
affiliation: The Weill Cornell Medicine
name: Shmuel Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: