TerminatedNot Applicable

Intra-procedural ECG Changes During TAVR

Stopped: Slow recruitment rate

United States43 participantsStarted 2023-06-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Identifying ECG changes during the TAVR procedure

Timeframe: 14 days

Trial details

NCT IDNCT05791344

SponsorCara Medical Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-23

View on ClinicalTrials.gov More Transcatheter Aortic Valve Replacement trials