Aortic ValvePure AR TAVRNCT03578952
Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation
A study testing TAVR with Evolut R valve in people with Aortic Valve and Aortic Valve Insufficiency, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Valve, Aortic Valve Insufficiency, Aortic Regurgitation
- What is being tested?
- TAVR with Evolut R valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2018to 21 Feb 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%).
- A candidate who does not meet [the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥8. In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
- There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
- The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
- The subject or the subject's legal representative 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) of the respective clinical site.
- The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
- The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
- The subject's age is 20 or more.
Who cannot join
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
- Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug-eluting coronary stent implantation).
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Need for emergency surgery for any reason.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
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- Active bacterial endocarditis or other active infections.
- Active peptic ulcer or upper GI bleeding within the prior 3 months.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- Life expectancy < 12 months due to non-cardiac comorbid conditions.
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle of aortic arch ≥200 degree),aortic arch atheroma (especially if thick [> 5mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
- Root disease including annuloaortic ectasia or aneurysm of root or sinus.
- Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity(with moderate or severe calcification and two or more severe curve (angle ≥90°) (applicable for transfemoral patients only).
- Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation Pilot Study
This study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).
- Conditions
- Aortic Valve, Aortic Valve Insufficiency, Aortic Regurgitation, Regurgitation, Aortic Valve, Aortic Incompetence
- Being tested
- TAVR with Evolut R valve
- Keywords
- TAVR, TAVI, Pure AR
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR with Evolut R valveDevice
TAVR with Evolut R valve
| Study group | Role | What they receive |
|---|---|---|
| Pure AR | Experimental | Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement. Receives: Device: TAVR with Evolut R valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic regurgitation
Measured: 1 month
Secondary outcomes (9)
All cause death
Measured: 1 month, 6 months, 1,2,3 and 5 years
Cardiovascular mortality
Measured: 1 month, 6 months, 1,2,3 and 5 years
Stroke
Valve Academic Research Consortium (VARC)
Measured: 1 month, 6 months, 1,2,3 and 5 years
Myocardial Infarction
Valve Academic Research Consortium (VARC)
Measured: 1 month, 6 months, 1,2,3 and 5 years
Re-hospitalization
Measured: 1 month, 6 months, 1,2,3 and 5 years
Acute kidney injury
Valve Academic Research Consortium (VARC)
Measured: 7 days
Vascular access site and access-related complication
Valve Academic Research Consortium (VARC)
Measured: 7 days
Bleeding
Valve Academic Research Consortium (VARC)
Measured: 7 days
Acute kidney injury
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start10 Aug 2018
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Why it stopped: End of support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578952
- Sponsor's protocol ID
- AMCCV2018-06
- Acronym
- Pure AR TAVR
- Status last verified
- Feb 2019
- First submitted
- 25 Jun 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation Pilot Study
- ClinicalTrials.gov ID
- NCT03578952
- Acronym / sponsor ID
- Pure AR TAVR / AMCCV2018-06
- Conditions
- Aortic Valve, Aortic Valve Insufficiency, Aortic Regurgitation, Regurgitation, Aortic Valve, Aortic Incompetence
- Keywords
- TAVR, TAVI, Pure AR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of support
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 6 Jul 2018 (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 study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pure AR | Experimental | Device: TAVR with Evolut R valvePatients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%).
- A candidate who does not meet [the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥8. In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
- There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
- The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
- The subject or the subject's legal representative 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) of the respective clinical site.
Key exclusion criteria (15 listed)
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
- Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug-eluting coronary stent implantation).
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Need for emergency surgery for any reason.
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 |
|---|---|---|
| TAVR with Evolut R valveTAVR with Evolut R valve | Device | Pure AR |
Primary outcome
Aortic regurgitation
Time frame: 1 month
9 secondary outcomes
All cause death
Time frame: 1 month, 6 months, 1,2,3 and 5 years
Cardiovascular mortality
Time frame: 1 month, 6 months, 1,2,3 and 5 years
Stroke
Time frame: 1 month, 6 months, 1,2,3 and 5 years
Myocardial Infarction
Time frame: 1 month, 6 months, 1,2,3 and 5 years
Re-hospitalization
Time frame: 1 month, 6 months, 1,2,3 and 5 years
Acute kidney injury
Time frame: 7 days
Vascular access site and access-related complication
Time frame: 7 days
Bleeding
Time frame: 7 days
Acute kidney injury
Time frame: 7 days
Results and safety
The study was stopped early (reason given: End of support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR with Evolut R valve in people with Aortic Valve and Aortic Valve Insufficiency, run by Seung-Jung Park at 1 site in South Korea.
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 8 inclusion and 15 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 22 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 South Korea. 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: End of support). 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?
Aortic regurgitation (time frame: 1 month). 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 22 Feb 2019.