NCT05465655

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 4, 2025

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

July 15, 2022

Last Update Submit

June 1, 2025

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Patients undergoing TAVR

EXPERIMENTAL

Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed notifying for New-Onset Conduction Disturbances (NOCD) using Cara Monitor.

Other: ECG monitoring for Conduction Disturbances

Interventions

ECG monitoring for Conduction DisturbancesOTHER

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Also known as: Continues ECG monitoring
Patients undergoing TAVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must meet be ≥ 18 years of age.
  • Must meet indications for TAVR using approved devices
  • Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  • Willing to comply with specified follow-up evaluations.
  • Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.

You may not qualify if:

  • 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.
  • Any contraindication to the TAVR procedure according to the instructions for use.
  • Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
  • Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackram F. Eleid, M.D.

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Helena Grinberg, PhD

    Cara Medical Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 20, 2022

Study Start

September 9, 2022

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

June 4, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)