Bicuspid Aortic ValveNCT03836521
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
An observational study of Bicuspid Aortic Valve, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 19 to 129 years
- Conditions the study is for
- Bicuspid Aortic Valve
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 15 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 129 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Who may be able to join
- Age≥18 years.
- Severe aortic stenosis with bicuspid anatomy.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVR.
Who cannot join
- Age <18 years
- Asymptomatic patients
- Pure aortic regurgitation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Sung-Han Yoon, M.D., 310-423-7426, Sunghan.Yoon@cshs.org
About this study
Official title: The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
- Conditions
- Bicuspid Aortic Valve
- Being tested
- Transcatheter aortic valve replacement
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause
Measured: 1 month
Death
Death from any cause
Measured: 1 year
Death
Death from any cause
Measured: 2 years
Death
Death from any cause
Measured: 3 years
Death
Death from any cause
Measured: 4 years
Death
Death from any cause
Measured: 5 years
Secondary outcomes (49)
Death from cardiac cause
Death from cardiac cause
Measured: 1 month
Death from cardiac cause
Death from cardiac cause
Measured: 1 year
Death from cardiac cause
Death from cardiac cause
Measured: 2 years
Death from cardiac cause
Death from cardiac cause
Measured: 3 years
Death from cardiac cause
Death from cardiac cause
Measured: 4 years
Death from cardiac cause
Death from cardiac cause
Measured: 5 years
Stroke
disabling and non-disabling stroke
Measured: 1 month
Stroke
disabling and non-disabling stroke
Measured: 1 year
Stroke
disabling and non-disabling stroke
Measured: 2 years
Stroke
disabling and non-disabling stroke
Measured: 3 years
Stroke
disabling and non-disabling stroke
Measured: 4 years
Stroke
disabling and non-disabling stroke
Measured: 5 years
Repeat hospitalization
Number of hospitalizations
Measured: 1 month
Repeat hospitalization
Number of hospitalizations
Measured: 1 year
Repeat hospitalization
Number of hospitalizations
Measured: 2 years
Repeat hospitalization
Number of hospitalizations
Measured: 3 years
Repeat hospitalization
Number of hospitalizations
Measured: 4 years
Repeat hospitalization
Number of hospitalizations
Measured: 5 years
Bleeding
Life-threatening or major bleeding rate
Measured: 1 month
Bleeding
Life-threatening or major bleeding rate
Measured: 1 year
Bleeding
Life-threatening or major bleeding rate
Measured: 2 years
Bleeding
Life-threatening or major bleeding rate
Measured: 3 years
Bleeding
Life-threatening or major bleeding rate
Measured: 4 years
Bleeding
Life-threatening or major bleeding rate
Measured: 5 years
Vascular complication
Major vascular complication
Measured: 1 month
Vascular complication
Major vascular complication
Measured: 1 year
Vascular complication
Major vascular complication
Measured: 2 years
Vascular complication
Major vascular complication
Measured: 3 years
Vascular complication
Major vascular complication
Measured: 4 years
Vascular complication
Major vascular complication
Measured: 5 years
Acute kidney injury (stage 2 or 3)
Measured: 1 month
Acute kidney injury (stage 2 or 3)
Measured: 1 year
Acute kidney injury (stage 2 or 3)
Measured: 2 years
Acute kidney injury (stage 2 or 3)
Measured: 3 years
Acute kidney injury (stage 2 or 3)
Measured: 4 years
Acute kidney injury (stage 2 or 3)
Measured: 5 years
Prosthetic regurgitation by Doppler echocardiography
Measured: at discharge
Prosthetic regurgitation by Doppler echocardiography
Measured: 1 month
Prosthetic regurgitation by Doppler echocardiography
Measured: 1 year
Prosthetic regurgitation by Doppler echocardiography
Measured: 2 years
Prosthetic regurgitation by Doppler echocardiography
Measured: 3 years
Prosthetic regurgitation by Doppler echocardiography
Measured: 4 years
Prosthetic regurgitation by Doppler echocardiography
Measured: 5 years
Mean aortic valve gradient by Doppler echocardiography
Measured: 1 month
Mean aortic valve gradient by Doppler echocardiography
Measured: 1 year
Mean aortic valve gradient by Doppler echocardiography
Measured: 2 years
Mean aortic valve gradient by Doppler echocardiography
Measured: 3 years
Mean aortic valve gradient by Doppler echocardiography
Measured: 4 years
Mean aortic valve gradient by Doppler echocardiography
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start15 Aug 2016
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic ValveStudies 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Makkar, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836521
- Sponsor's protocol ID
- Pro00047203
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Yoon SH, Kim WK, Dhoble A, Milhorini Pio S, Babaliaros V, Jilaihawi H, Pilgrim T, De Backer O, Bleiziffer S, Vincent F, Shmidt T, Butter C, Kamioka N, Eschenbach L, Renker M, Asami M, Lazkani M, Fujita B, Birs A, Barbanti M, Pershad A, Landes U, Oldemeyer B, Kitamura M, Oakley L, Ochiai T, Chakravarty T, Nakamura M, Ruile P, Deuschl F, Berman D, Modine T, Ensminger S, Kornowski R, Lange R, McCabe JM, Williams MR, Whisenant B, Delgado V, Windecker S, Van Belle E, Sondergaard L, Chevalier B, Mack M, Bax JJ, Leon MB, Makkar RR; Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Sep 1;76(9):1018-1030. doi: 10.1016/j.jacc.2020.07.005.
PubMed 32854836
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
- ClinicalTrials.gov ID
- NCT03836521
- Acronym / sponsor ID
- Pro00047203
- Conditions
- Bicuspid Aortic Valve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 11 Feb 2019 (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 objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 129 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Key inclusion criteria (4 listed)
- Age≥18 years.
- Severe aortic stenosis with bicuspid anatomy.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVR.
Key exclusion criteria (3 listed)
- Age <18 years
- Asymptomatic patients
- Pure aortic regurgitation.
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 |
|---|---|---|
| Transcatheter aortic valve replacement | Device | – |
Primary outcome
Death
Time frame: 1 month
Death from any cause
Death
Time frame: 1 year
Death from any cause
Death
Time frame: 2 years
Death from any cause
Death
Time frame: 3 years
Death from any cause
Death
Time frame: 4 years
Death from any cause
Death
Time frame: 5 years
Death from any cause
49 secondary outcomes
Death from cardiac cause
Time frame: 1 month
Death from cardiac cause
Time frame: 1 year
Death from cardiac cause
Time frame: 2 years
Death from cardiac cause
Time frame: 3 years
Death from cardiac cause
Time frame: 4 years
Death from cardiac cause
Time frame: 5 years
Stroke
Time frame: 1 month
Stroke
Time frame: 1 year
Stroke
Time frame: 2 years
Stroke
Time frame: 3 years
Stroke
Time frame: 4 years
Stroke
Time frame: 5 years
Repeat hospitalization
Time frame: 1 month
Repeat hospitalization
Time frame: 1 year
Repeat hospitalization
Time frame: 2 years
Repeat hospitalization
Time frame: 3 years
Repeat hospitalization
Time frame: 4 years
Repeat hospitalization
Time frame: 5 years
Bleeding
Time frame: 1 month
Bleeding
Time frame: 1 year
Bleeding
Time frame: 2 years
Bleeding
Time frame: 3 years
Bleeding
Time frame: 4 years
Bleeding
Time frame: 5 years
Vascular complication
Time frame: 1 month
Vascular complication
Time frame: 1 year
Vascular complication
Time frame: 2 years
Vascular complication
Time frame: 3 years
Vascular complication
Time frame: 4 years
Vascular complication
Time frame: 5 years
Acute kidney injury (stage 2 or 3)
Time frame: 1 month
Acute kidney injury (stage 2 or 3)
Time frame: 1 year
Acute kidney injury (stage 2 or 3)
Time frame: 2 years
Acute kidney injury (stage 2 or 3)
Time frame: 3 years
Acute kidney injury (stage 2 or 3)
Time frame: 4 years
Acute kidney injury (stage 2 or 3)
Time frame: 5 years
Prosthetic regurgitation by Doppler echocardiography
Time frame: at discharge
Prosthetic regurgitation by Doppler echocardiography
Time frame: 1 month
Prosthetic regurgitation by Doppler echocardiography
Time frame: 1 year
Prosthetic regurgitation by Doppler echocardiography
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Derived from this study: PubMed 32854836Yoon SH, Kim WK, Dhoble A, Milhorini Pio S, Babaliaros V, Jilaihawi H, Pilgrim T, De Backer O, Bleiziffer S, Vincent F, Shmidt T, Butter C, Kamioka N, Eschenbach L, Renker M, Asami M, Lazkani M, Fujita B, Birs A, Barbanti M, Pershad A, Landes U, Oldemeyer B, Kitamura M, Oakley L, Ochiai T, Chakravarty T, Nakamura M, Ruile P, Deuschl F, Berman D, Modine T, Ensminger S, Kornowski R, Lange R, McCabe JM, Williams MR, Whisenant B, Delgado V, Windecker S, Van Belle E, Sondergaard L, Chevalier B, Mack M, Bax JJ, Leon MB, Makkar RR; Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Sep 1;76(9):1018-1030. doi: 10.1016/j.jacc.2020.07.005.
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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.
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 Bicuspid Aortic Valve, run by Cedars-Sinai Medical Center 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: looking for participants now, as of the sponsor's last update on 11 Feb 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Han Yoon, M.D. (3104237426, Sunghan.Yoon@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836521, which also lists 1 linked publication.
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 11 Feb 2019.