Aortic Valve StenosisNCT05189886
Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
An observational study of Aortic Valve Stenosis, run by Community Memorial Health System at 1 site in United States.
Trial summary
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Double Balloon Valvuloplasty in TAVR
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 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: A patient with moderate to severe aortic regurgitation requiring replacement of his/her aortic valve.
Who may be able to join
- Male or female ≥18 years of age
- Diagnosis of severe native valve aortic stenosis
- Meets the standard of care indications to undergo TAVR procedure (aortic valve area <1.0 cm2 or mean pressure gradient >40 mmHg or peak velocity >4.0 m/s or aortic valve area index <0.6).
- Provided informed consent.
Who cannot join
- History of prior aortic valve replacement
- Pre-existing moderate to severe aortic regurgitation
- Lacking pre-procedure echocardiogram
- Patients planning to undergo multiple valve replacements simultaneously
- Intraoperative arrhythmia
- Intraoperative hemodynamic instability
- Intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection)
- At the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Community Memorial Hospital
Ventura, California, 93003
Erin Ross, 805-948-8278, eross1@cmhshealth.org
About this study
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. The investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. Less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. Furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion.
The primary objective of this study is to determine if double valve inflation during a TAVR procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Double Balloon Valvuloplasty in TAVR
- Keywords
- TAVR, Balloon Valvuloplasty
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Balloon Valvuloplasty in TAVRProcedure or surgery
The prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs. Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria. All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated. Echocardiogram results and procedure details will be collected as data. At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram. Details from that follow-up visit and the echocardiogram results will be collected as data. Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | The prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs. Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria. All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated. Echocardiogram results and procedure details will be collected as data. At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram. Details from that follow-up visit and the echocardiogram results will be collected as data. Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first. Receives: Procedure: Double Balloon Valvuloplasty in TAVR | |
| Retrospective | The retrospective phase will collect data from previous TAVR procedures completed between February 2019 and October 1, 2021. Data from up to 200 patient charts will be collected using the Society of Thoracic Surgeons/American College of Cardiology that is maintained by the CMH Cardiology Department. The population will be de-identified as the purpose is to obtain descriptive information from the medical records to utilize for propensity match scoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve area
Valve area as measured by echocardiogram
Measured: Immediately following the procedure
Valve area
Valve area as measured by echocardiogram
Measured: At 30 days follow up
Mean gradient
Mean gradient as measured by echocardiogram
Measured: Immediately following the procedure
Mean gradient
Mean gradient as measured by echocardiogram
Measured: At 30 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Nov 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Memorial Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Wan, Community Memorial Health System
- Investigators
- Jennifer Wan, MD, Principal investigator, Community Memorial HealthCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189886
- Sponsor's protocol ID
- 2021-HSR013
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 13 Jan 2022
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
- ClinicalTrials.gov ID
- NCT05189886
- Acronym / sponsor ID
- 2021-HSR013
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVR, Balloon Valvuloplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Community Memorial Health SystemUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jan 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.
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. The investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. Less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. Furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion.
The primary objective of this study is to determine if double valve inflation during a TAVR procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Procedure: Double Balloon Valvuloplasty in TAVRThe prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs. Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria. All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated. Echocardiogram results and procedure details will be collected as data. At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram. Details from that follow-up visit and the echocardiogram results will be collected as data. Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first. |
| Retrospective | – | –The retrospective phase will collect data from previous TAVR procedures completed between February 2019 and October 1, 2021. Data from up to 200 patient charts will be collected using the Society of Thoracic Surgeons/American College of Cardiology that is maintained by the CMH Cardiology Department. The population will be de-identified as the purpose is to obtain descriptive information from the medical records to utilize for propensity match scoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient with moderate to severe aortic regurgitation requiring replacement of his/her aortic valve.
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age
- Diagnosis of severe native valve aortic stenosis
- Meets the standard of care indications to undergo TAVR procedure (aortic valve area <1.0 cm2 or mean pressure gradient >40 mmHg or peak velocity >4.0 m/s or aortic valve area index <0.6).
- Provided informed consent.
Key exclusion criteria (8 listed)
- History of prior aortic valve replacement
- Pre-existing moderate to severe aortic regurgitation
- Lacking pre-procedure echocardiogram
- Patients planning to undergo multiple valve replacements simultaneously
- Intraoperative arrhythmia
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 |
|---|---|---|
| Double Balloon Valvuloplasty in TAVRThe prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs. Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria. All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated. Echocardiogram results and procedure details will be collected as data. At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram. Details from that follow-up visit and the echocardiogram results will be collected as data. Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first. | Procedure or surgery | Prospective |
Primary outcome
Valve area
Time frame: Immediately following the procedure
Valve area as measured by echocardiogram
Valve area
Time frame: At 30 days follow up
Valve area as measured by echocardiogram
Mean gradient
Time frame: Immediately following the procedure
Mean gradient as measured by echocardiogram
Mean gradient
Time frame: At 30 days follow up
Mean gradient as measured by echocardiogram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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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.
Jennifer Wan, MD principal investigator
Community Memorial HealthCenter
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 Aortic Valve Stenosis, run by Community Memorial 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Ross (8059488278, eross1@cmhshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve area (time frame: Immediately following the procedure). The study lists 4 primary outcomes in all. 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 13 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.