Transcatheter Aortic Valve Replacement Clinical Trial
— Cara CDRMOfficial title:
Pilot Study to Estimate a Reduction of TAVR Associated Conduction Disturbance Through Notification of Cara Monitor During TAVR Procedure
Prospective, multicenter, roll-in, pilot clinical trial. Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD). The study will be conducted in two stages: During the first roll-in stage of the study, 50 intended to undergo TAVR (all comers) will be enrolled. Data will be collected according to the study schedule below of pre-, during and after the TAVR procedure up to 14 days FU. This data for the first 50 patients will be analyzed to evaluate the ability of the Cara Monitor prediction of NOCD post TAVR. The second stage of the stage will be conducted upon completion of the first stage analysis and will be considered to randomize 1:1 the subjects connected to Cara Monitor during the procedure versus site-specific current practice. The effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice will be estimated.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Must meet be = 18 years of age. 2. Must meet indications for TAVR using approved devices 3. Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. 4. Willing to comply with specified follow-up evaluations. 5. Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements. Exclusion Criteria: 1. Any implanted device or 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. Less than the legal age of consent, legally incompetent, or otherwise vulnerable. 4. Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period. |
Country | Name | City | State |
---|---|---|---|
United States | Mackram F. Eleid, M.D. | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Cara Medical Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD) | Estimate the reduction of NOCD (percentage) at 14 days post TAVR while using Cara Monitor | 14 days | |
Primary | Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB) | Estimate the reduction (a percentage) of PPM or High-Grade AV Block (HGAVB) | 14 days | |
Primary | Evaluate Cara usability using a dedicated questioner | Estimate learning curve of using CaraTM system (e.g. the experience required with system for achieving above improvements) | 1 Day of Procedure | |
Primary | Evaluate Cara Safety, collecting Adverse Events | During the study patients will be followed for any adverse events relevant to the TAVR procedure as defined in the CRF | 14 days |
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