Aortic StenosisNCT04489095
Conduction Disease After Transcatheter Aortic Valve Replacement
A study testing Electrophysiology Study in people with Aortic Stenosis and Heart Block, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Heart Block, Aortic Insufficiency
- What is being tested?
- Electrophysiology Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 1 Aug 2022
- Phase
- Interventional
- 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
Who may be able to join
- Signed and dated Informed Consent
- Patient that undergoes a TAVR
- Ability to complete functional assessments.
Who cannot join
- Patients with pre-existing permanent pacemaker.
- Patient unwilling or unable to follow-up for necessary pre- and post-procedure clinical assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement
This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients, which has been elusive, can be developed.
Read the detailed description
TAVR is a very commonly performed procedure throughout the world; it has become standard of care as the treatment for aortic stenosis and is performed in hundreds of thousands of patients annually. TAVR affords patients therapies that prolong life and improve quality of life; furthermore, these therapies afford certain patients who are not candidates for surgical options hope for the future. Adults undergoing TAVR may suffer the complication of requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still don't understand how to best predict this complication; in fact some patients that ultimately need a pacemaker don't get one after the procedure and some that get a pacemaker are found to ultimately not have really needed it. A better understanding of which patients do and do not need pacemakers will help prevent complications of high grade block in those without pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker implantation (infection, tricuspid regurgitation).
Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent incremental value, above and beyond other parameters, for the prediction of high-grade heart block after TAVR. The goal is to understand conduction disease changes before and after TAVR, coupled with other patient and procedural factors that can help create a management algorithm for conduction disease after TAVR.
Primary endpoint: to find correlation coefficients between a) absolute and delta values of various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted after TAVR.
Methods: Patients will receive EPS immediately before and after TAVR (while on the catheterization lab table for TAVR procedure) and then again the next day; this information will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither. The investigators will study which parameters obtained during the EPS, in addition to other known/suspected predictors of conduction disease after TAVR, best correlate with serious problems with the heart's electrical conduction system as determined by clinical follow-up.
Anticipated findings: that the EPS findings add incremental and independent value in predicting which patients will develop high grade conduction disease.
- Conditions
- Aortic Stenosis, Heart Block, Aortic Insufficiency
- Being tested
- Electrophysiology Study
- Keywords
- Transcatheter Aortic Valve Replacement, TAVR, Aortic stenosis, AS, Pacemaker, HV interval, Electrophysiology Study, EPS, Heart block
- Medical subject headings
- Aortic Valve Stenosis, Heart Block, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiology StudyDiagnostic test
After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiology Study pre and Post TAVR | Experimental | In all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring. Receives: Diagnostic Test: Electrophysiology Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
High grade conduction disease post TAVR
Number of participants that develop high grade conduction block post TAVR including complete heart block, 2nd degree AV block, symptomatic bradycardia
Measured: 1 year
Secondary outcomes (5)
death
Rate of mortality by chart review and SSDI query at 1 year
Measured: 1 year
rehospitalization
Absolute and per patient hospitalizations post index procedure
Measured: 1 year
need for pacemaker implantation
Percentage of participants requiring permanent pacemaker implantation in index hospitalization or within 1 year
Measured: 1 year
HV interval pre and post TAVR
Absolute HV interval in milliseconds as measure by electrophysiology study for each participant pre and post TAVR
Measured: 2 days
ejection fraction
Ejection fraction as measured by trans-thoracic echocardiography for each participant pre and post tavr on routine trans-thoracic echocardiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start16 Jul 2020
- Primary completion17 Feb 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS(Electrophysiology study) will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Tiberio Frisoli, Henry Ford Health System
- Investigators
- Tiberio Frisoli, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489095
- Sponsor's protocol ID
- Frisoli_13944
- Status last verified
- Dec 2022
- First submitted
- 28 May 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04489095
- Acronym / sponsor ID
- Frisoli_13944
- Conditions
- Aortic Stenosis, Heart Block, Aortic Insufficiency
- Keywords
- Transcatheter Aortic Valve Replacement, TAVR, Aortic stenosis, AS, Pacemaker, HV interval, Electrophysiology Study, EPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 28 Jul 2020 (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.
This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients, which has been elusive, can be developed.
Detailed description
TAVR is a very commonly performed procedure throughout the world; it has become standard of care as the treatment for aortic stenosis and is performed in hundreds of thousands of patients annually. TAVR affords patients therapies that prolong life and improve quality of life; furthermore, these therapies afford certain patients who are not candidates for surgical options hope for the future. Adults undergoing TAVR may suffer the complication of requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still don't understand how to best predict this complication; in fact some patients that ultimately need a pacemaker don't get one after the procedure and some that get a pacemaker are found to ultimately not have really needed it. A better understanding of which patients do and do not need pacemakers will help prevent complications of high grade block in those without pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker implantation (infection, tricuspid regurgitation).
Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent incremental value, above and beyond other parameters, for the prediction of high-grade heart block after TAVR. The goal is to understand conduction disease changes before and after TAVR, coupled with other patient and procedural factors that can help create a management algorithm for conduction disease after TAVR.
Primary endpoint: to find correlation coefficients between a) absolute and delta values of various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted after TAVR.
Methods: Patients will receive EPS immediately before and after TAVR (while on the catheterization lab table for TAVR procedure) and then again the next day; this information will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither. The investigators will study which parameters obtained during the EPS, in addition to other known/suspected predictors of conduction disease after TAVR, best correlate with serious problems with the heart's electrical conduction system as determined by clinical follow-up.
Anticipated findings: that the EPS findings add incremental and independent value in predicting which patients will develop high grade conduction disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS(Electrophysiology study) will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
| Arm | Type | Receives |
|---|---|---|
| Electrophysiology Study pre and Post TAVR | Experimental | Diagnostic Test: Electrophysiology StudyIn all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated Informed Consent
- Patient that undergoes a TAVR
- Ability to complete functional assessments.
Key exclusion criteria (2 listed)
- Patients with pre-existing permanent pacemaker.
- Patient unwilling or unable to follow-up for necessary pre- and post-procedure clinical assessments.
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 |
|---|---|---|
| Electrophysiology StudyAfter informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above. | Diagnostic test | Electrophysiology Study pre and Post TAVR |
Primary outcome
High grade conduction disease post TAVR
Time frame: 1 year
Number of participants that develop high grade conduction block post TAVR including complete heart block, 2nd degree AV block, symptomatic bradycardia
5 secondary outcomes
death
Time frame: 1 year
rehospitalization
Time frame: 1 year
need for pacemaker implantation
Time frame: 1 year
HV interval pre and post TAVR
Time frame: 2 days
ejection fraction
Time frame: 1 year
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 14 Dec 2022.
- 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.
Tiberio Frisoli, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiology Study in people with Aortic Stenosis and Heart Block, run by Henry Ford Health System 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 3 inclusion and 2 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 14 Dec 2022. 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 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?
High grade conduction disease post TAVR (time frame: 1 year). 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 14 Dec 2022.