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Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

Sponsor
K2 Medical Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05465655
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
16.5
Anticipated Duration (Months)
30.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ECG monitoring for Conduction Disturbances
 N/A

Detailed Description

Data to be collected during the study procedure for both stages:

  1. Pre-procedure

  2. Demographics

  3. Cardiac CT (Dicom/disk with raw data ) and analysis 3Menzio

  4. 12 lead ECG

  5. 12 lead Holter for at least 1-hour pre-procedure

  6. Procedure

  7. Continuous 3-12 lead Holter will be supplied by the study sponsor, and data will be collected and analyzed by the study sponsor

  8. Fluoroscopy (captured automatically by video system )

  9. Hemodynamics (captured automatically by video system2)

  10. Device manufacturer (type) and size

  11. Post-procedure (in hospital)

  12. Daily 12 lead ECG

  13. Continuous 3-12 lead Holter

  14. Post-procedure (after discharge)

  1. Continuous 1-3 lead Holter for 14 days will be supplied by the study sponsor, the data from the Holter recordings will be collected from the patient's home and analyzed by the study sponsor.

  1. Follow up:

  2. 30 days follow-up hospital visit:

  • Cardiac echo

  • 12 lead ECG

  1. 6 month - Clinical FU phone call according to standard procedure

  2. 12 months Clinical FU phone call according to standard procedure

Conduction Disturbances (CD) outcome will be subdivided into:

  1. PPM or High-Grade AV Block (HGAVB)

  2. All other new onset (or deterioration) of CD that are not listed in #1

  3. No new onset CD

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Study to Estimate a Reduction of TAVR Associated Conduction Disturbance Through Notification of Cara Monitor During TAVR Procedure
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAVR

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
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
Other Names:
  • Continues ECG monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD) [14 days]

      Estimate the reduction of NOCD (percentage) at 14 days post TAVR while using Cara Monitor

    2. Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB) [14 days]

      Estimate the reduction (a percentage) of PPM or High-Grade AV Block (HGAVB)

    3. Evaluate Cara usability using a dedicated questioner [1 Day of Procedure]

      Estimate learning curve of using CaraTM system (e.g. the experience required with system for achieving above improvements)

    4. Evaluate Cara Safety, collecting Adverse Events [14 days]

      During the study patients will be followed for any adverse events relevant to the TAVR procedure as defined in the CRF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mackram F. Eleid, M.D. Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • K2 Medical Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    K2 Medical Ltd
    ClinicalTrials.gov Identifier:
    NCT05465655
    Other Study ID Numbers:
    • Cara 2.0
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Jul 20, 2022