Transcatheter Aortic Valve ReplacementNCT05791344
Intra-procedural ECG Changes During TAVR
An observational study of Transcatheter Aortic Valve Replacement and Conduction Disturbance, run by Cara Medical Ltd at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Conduction Disturbance
- What is being tested?
- ECG monitoring
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 31 Dec 2024
- 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: Subjects with a diagnosis of severe aortic stenosis (AS) undergoing TAVR with a commercially available valve, who meet the inclusion and exclusion criteria, will be eligible for participation in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Weill Cornell Medicine
New York, New York, 10065
About this study
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.
Read the detailed description
Transcatheter aortic valve replacement (TAVR) has become a well-established alternative to surgical intervention for patients with severe symptomatic aortic stenosis (AS) (1-4). The rates of most TAVR complications have declined over time due to the improvement of operator experience and technological advancement; however, conduction abnormalities continue to persist (5). New-onset left bundle branch block (LBBB) and atrioventricular nodal block (AVB) are among the most common conduction disturbances (6). Additionally, there is an increased incidence of delayed (after discharge) HAVB (2nd-degree AVB Mobitz type 2 or 3rd-degree AVB) in patients with preexisting (pre-TAVR) right bundle branch block (RBBB) and new-onset LBBB post-TAVR, 13.2%, and 8.5%, respectively (7).
Currently, conduction disturbances post-TAVR are assessed via post-procedural ECG, and physicians performing TAVR are not provided feedback in real time. The use of intraprocedural ECG could provide insight into the status of the heart's conduction system during TAVR and prevent irreversible injury, requiring post-procedural monitoring at intensive cardiac care unit (usually with a temporary pacemaker in situ) or even permanent pacemaker implantation. Furthermore, given the increased incidence of HAVB after valve replacement in patients with preexisting RBBB and new-onset LBBB, continued post-procedural ECG monitoring in this particular subset of patients may provide more information on the progression of conduction disturbances after TAVR.
This will be a small-scale, early feasibility study evaluating intra-procedural ECG changes, such as AVB (1st, 2nd, or 3rd degree), or new-onset LBBB, in patients undergoing TAVR, to inform a future, larger scale, prospective investigation.
- 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
Also called Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
Intra-procedural ECG changes during TAVR
| 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.
Identifying ECG changes during the TAVR procedure
Identifying intra-procedural ECG changes (such as prolongation of the PR interval or QRS or changes in QRS axis) that may be associated with post TAVR persistent conduction disturbances (AVB or LBBB) at discharge. LBBB).
Measured: 14 days
Secondary outcomes (2)
Identifying predictors of conduction disturbances (AVB or LBBB) after TAVR
Identifying predictors on intra-procedural ECG for late-onset (after discharge) high degree AVB.
Measured: 30 days
Evaluating rates of conduction disturbances (AVB or LBBB) after TAVR
Evaluating rates of late-onset (after discharge) high-degree AVB (HAVB = second-degree AVB Mobitz type 2 or third-degree AVB) after TAVR.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start21 Jun 2023
- Primary completion23 Jul 2024
- Study completion31 Dec 2024
Why it stopped: Slow recruitment rate
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
- Cohort
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shmuel Chen, MD, PhD, Principal investigator, The Weill Cornell Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791344
- Sponsor's protocol ID
- 22-07025053
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-procedural ECG Changes During TAVR
- ClinicalTrials.gov ID
- NCT05791344
- Acronym / sponsor ID
- 22-07025053
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cara Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Mar 2023 (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.
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.
Detailed description
Transcatheter aortic valve replacement (TAVR) has become a well-established alternative to surgical intervention for patients with severe symptomatic aortic stenosis (AS) (1-4). The rates of most TAVR complications have declined over time due to the improvement of operator experience and technological advancement; however, conduction abnormalities continue to persist (5). New-onset left bundle branch block (LBBB) and atrioventricular nodal block (AVB) are among the most common conduction disturbances (6). Additionally, there is an increased incidence of delayed (after discharge) HAVB (2nd-degree AVB Mobitz type 2 or 3rd-degree AVB) in patients with preexisting (pre-TAVR) right bundle branch block (RBBB) and new-onset LBBB post-TAVR, 13.2%, and 8.5%, respectively (7).
Currently, conduction disturbances post-TAVR are assessed via post-procedural ECG, and physicians performing TAVR are not provided feedback in real time. The use of intraprocedural ECG could provide insight into the status of the heart's conduction system during TAVR and prevent irreversible injury, requiring post-procedural monitoring at intensive cardiac care unit (usually with a temporary pacemaker in situ) or even permanent pacemaker implantation. Furthermore, given the increased incidence of HAVB after valve replacement in patients with preexisting RBBB and new-onset LBBB, continued post-procedural ECG monitoring in this particular subset of patients may provide more information on the progression of conduction disturbances after TAVR.
This will be a small-scale, early feasibility study evaluating intra-procedural ECG changes, such as AVB (1st, 2nd, or 3rd degree), or new-onset LBBB, in patients undergoing TAVR, to inform a future, larger scale, prospective investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- 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
- Subjects with a diagnosis of severe aortic stenosis (AS) undergoing TAVR with a commercially available valve, who meet the inclusion and exclusion criteria, will be eligible for participation in this study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 monitoringAlso: Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedureIntra-procedural ECG changes during TAVR | Device | ECG Monitoring -TAVR patients |
Primary outcome
Identifying ECG changes during the TAVR procedure
Time frame: 14 days
Identifying intra-procedural ECG changes (such as prolongation of the PR interval or QRS or changes in QRS axis) that may be associated with post TAVR persistent conduction disturbances (AVB or LBBB) at discharge. LBBB).
2 secondary outcomes
Identifying predictors of conduction disturbances (AVB or LBBB) after TAVR
Time frame: 30 days
Evaluating rates of conduction disturbances (AVB or LBBB) after TAVR
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
Shmuel Chen, MD, PhD principal investigator
The Weill Cornell Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement and Conduction Disturbance, run by Cara Medical Ltd at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 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 1 site in United States. 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 was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
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?
Identifying ECG changes during the TAVR procedure (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 4 Jun 2025.