Transcatheter Aortic Valve ReplacementCDRSNCT05657912
Cara CDRS (Conduction Disturbance Risk Score) 1.0
An observational study of Transcatheter Aortic Valve Replacement, run by Cara Medical Ltd at 3 sites in 3 countries.
Trial summary
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study. Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD are frequent complications of TAVR that have been shown to be associated with increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- ECG monitoring
- Type of treatment
- Medical device
- How many people
- 355 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 12 Dec 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600 patients undergoing TAVR will be enrolled at the investigational sites.
Who may be able to join
- 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.
Who cannot join
- Any implanted device or an indication for treatment with a 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec
About this study
Official title: A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS).
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study.
Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD are frequent complications of TAVR that have been shown to be associated with increased mortality and re-hospitalization rates.
Read more
The purpose of the study is to collect continuous ECG data in order to validate the performance of the Cara Conduction Disturbance Risk Score (CDRS) in patients undergoing transcatheter aortic valve replacement (TAVR).
Subjects will be studied during the TAVR procedure and their ECG recordings according to the study schedule below of pre-, during, and after the TAVR procedure up to 14/30 days FU will be collected.
600 patients will be enrolled in this study with the hypothesis that Cara can deliver a statistically significant conduction disturbance risk stratification for patients undergoing TAVR.
No investigation intervention is planned during this study. The Cara System analysis will be performed offline.
Read the detailed description
TAVR will be performed using site investigators' best practices including the use of standard-of-care catheters, devices, imaging, and monitoring modalities.
Data will be collected to include the following patients' measures during this study:
- Pre-procedure
- Demographics
- Medical history
- Cardiac CT
- 12 lead ECG
- Procedure
- Continuous 3-12 lead Holter will be supplied, data will be collected and analyzed by the study sponsor
- Fluoroscopy (captured automatically by video system )
- Device manufacturer (type) and size
- Post-procedure (in hospital)
- Continuous 1-3 lead Holter for 14 days will be supplied, and the data from the Holter recordings will be collected from the patient's home and analyzed.
- Post-procedure (discharge)
- 12 lead ECG
- Patients will be followed according to the current medical practice.
Data to be collected during the FU :
- 12 lead ECG at 14/30 days
The data collected from the study will be used to evaluate the performance Cara System, a conduction disturbance monitor that provides an indication of conduction disturbances during TAVR procedures.
Conduction Disturbances (CD) outcome will be subdivided into:
- PPM or High-Grade AV Block (HGAVB)
- All other new onsets (or deterioration) of CD that are not listed in #1
- No new onset CD
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- ECG monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoringDevice
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
| Study group | Role | What they receive |
|---|---|---|
| ECG Monitoring -TAVR patients | Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure Receives: Device: ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor
Continuous ECG data collected during the TAVR procedure will be used to retrospectively evaluate the performance of the Cara monitor Conduction Disturbance Risk Score (CDRS) in patients post- TAVR procedure.
Measured output:
- Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+)
- Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start12 Dec 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Grinberg-Rashi, PhD, Study chair, helenag@k2-medicalltd.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657912
- Sponsor's protocol ID
- Cara 1.0
- Acronym
- CDRS
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS).
- ClinicalTrials.gov ID
- NCT05657912
- Acronym / sponsor ID
- CDRS / Cara 1.0
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Cara Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study.
Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD are frequent complications of TAVR that have been shown to be associated with increased mortality and re-hospitalization rates.
The purpose of the study is to collect continuous ECG data in order to validate the performance of the Cara Conduction Disturbance Risk Score (CDRS) in patients undergoing transcatheter aortic valve replacement (TAVR).
Subjects will be studied during the TAVR procedure and their ECG recordings according to the study schedule below of pre-, during, and after the TAVR procedure up to 14/30 days FU will be collected.
600 patients will be enrolled in this study with the hypothesis that Cara can deliver a statistically significant conduction disturbance risk stratification for patients undergoing TAVR.
No investigation intervention is planned during this study. The Cara System analysis will be performed offline.
Detailed description
TAVR will be performed using site investigators' best practices including the use of standard-of-care catheters, devices, imaging, and monitoring modalities.
Data will be collected to include the following patients' measures during this study:
- Pre-procedure
- Demographics
- Medical history
- Cardiac CT
- 12 lead ECG
- Procedure
- Continuous 3-12 lead Holter will be supplied, data will be collected and analyzed by the study sponsor
- Fluoroscopy (captured automatically by video system )
- Device manufacturer (type) and size
- Post-procedure (in hospital)
- Continuous 1-3 lead Holter for 14 days will be supplied, and the data from the Holter recordings will be collected from the patient's home and analyzed.
- Post-procedure (discharge)
- 12 lead ECG
- Patients will be followed according to the current medical practice.
Data to be collected during the FU :
- 12 lead ECG at 14/30 days
The data collected from the study will be used to evaluate the performance Cara System, a conduction disturbance monitor that provides an indication of conduction disturbances during TAVR procedures.
Conduction Disturbances (CD) outcome will be subdivided into:
- PPM or High-Grade AV Block (HGAVB)
- All other new onsets (or deterioration) of CD that are not listed in #1
- No new onset CD
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG Monitoring -TAVR patients | – | Device: ECG monitoringContinuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600 patients undergoing TAVR will be enrolled at the investigational sites.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Any implanted device or an indication for treatment with a 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoringContinuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure | Device | ECG Monitoring -TAVR patients |
Primary outcome
Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor
Time frame: 14 days
Continuous ECG data collected during the TAVR procedure will be used to retrospectively evaluate the performance of the Cara monitor Conduction Disturbance Risk Score (CDRS) in patients post- TAVR procedure. Measured output: 1. Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+) 2. Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Grinberg-Rashi, PhD study chair
helenag@k2-medicalltd.com
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement, run by Cara Medical Ltd at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.