Aortic Valve StenosisPhase 4TRANSITNCT02838199
TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
A Phase 4 study testing SAPIEN 3 and SAVR in people with Aortic Valve Stenosis, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- SAPIEN 3 and SAVR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Dec 2030
- Phase
- Phase 4
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age must be at least 19 and less than 75 years old
- Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm2. Echocardiogram must be within 3 months of the date of the procedure
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Life expectancy <1 year due to medical illness
- Suspected Malignancy
- Inoperability evaluated by surgeon
- Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
- Concomitant severe mitral valve or significant aorta disease requiring surgery
- Active bacterial endocarditis within 6 months of procedure
Show all 12Show fewer
- Leukopenia (WBC<3000 cell/mL), acute anemia (Hgb<8g/dL), thrombocytopenia (platelet < 50000 cell/mL)
- Intracardiac thrombus
- A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- Native aortic annulus size < 18 mm or > 25 mm as measured by echocardiogram.
- Expectation that patient will not improve despite treatment of aortic stenosis
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis
- Being tested
- SAPIEN 3, SAVR
- Keywords
- Transcatheter aortic valve replacement, TAVR, TAVI, SAVR
- 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.
SAPIEN 3Device
SAVRProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TAVR | Experimental | Transcatheter aortic valve replacement with SAPIEN 3 Receives: Device: SAPIEN 3 |
| SAVR | Active comparator | Surgical aortic valve replacement Receives: Procedure: SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
event rate of all-cause mortality
Measured: 1 year
Secondary outcomes (25)
event rate of cardiovascular mortality
Measured: 30 days or hospital discharge, whichever is longer
event rate of cardiovascular mortality
Measured: 31 days to the 1 year
event rate of myocardial Infarction
Measured: 30 days or hospital discharge, whichever is longer
event rate of myocardial Infarction
Measured: 31 days to the 1 year
event rate of all Stroke and transient ischemic attack
Measured: 30 days or hospital discharge, whichever is longer
event rate of all Stroke and transient ischemic attack
Measured: 31 days to the 1 year
event rate of bleeding
Measured: 30 days or hospital discharge, whichever is longer
event rate of bleeding
Measured: 31 days to the 1 year
event rate of vascular access site and access-related complication
Measured: 30 days or hospital discharge, whichever is longer
event rate of vascular access site and access-related complication
Measured: 31 days to the 1 year
event rate of acute kidney injury
Measured: 30 days or hospital discharge, whichever is longer
event rate of acute kidney injury
Measured: 31 days to the 1 year
event rate of permanent pacemaker insertion
Measured: 30 days or hospital discharge, whichever is longer
event rate of permanent pacemaker insertion
Measured: 31 days to the 1 year
event rate of other TAVR-related complication
Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
Measured: 30 days or hospital discharge, whichever is longer
event rate of other TAVR-related complication
Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
Measured: 31 days to the 1 year
event rate of prosthetic valve dysfunction
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
Measured: 30 days or hospital discharge, whichever is longer
event rate of prosthetic valve dysfunction
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
Measured: 31 days to the 1 year
event rate of composite event for device success, early safety, clinical efficacy
Number of cases with following events ;
- Device success or
- Early safety (At 30 days):
All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.
or
- Clinical efficacy (After 30 days):
All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction.
Measured: 30 days or hospital discharge, whichever is longer
event rate of composite event for device success, early safety, clinical efficacy
Number of cases with following events ;
- Device success or
- Early safety (At 30 days):
All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.
or
- Clinical efficacy (After 30 days):
All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction.
Measured: 31 days to the 1 year
event rate of structural valve deterioration
Measured: 30 days or hospital discharge, whichever is longer
event rate of structural valve deterioration
Measured: 31 days to the 1 year
NYHA (New York Heart Association Functional Classification)
Measured: 30days and 1 year
Valve area
Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.
Measured: 30days and 1 year
event rate of free from atrial fibrillation
Measured: 30days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2020 (estimated)
- Study completionDec 2030 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- Investigators
- Suck-jung Choo, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838199
- Sponsor's protocol ID
- AMCCV2016-16
- Acronym
- TRANSIT
- Status last verified
- Nov 2016
- First submitted
- 6 Jul 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT02838199
- Acronym / sponsor ID
- TRANSIT / AMCCV2016-16
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter aortic valve replacement, TAVR, TAVI, SAVR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Dec 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- 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 determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR | Experimental | Device: SAPIEN 3Transcatheter aortic valve replacement with SAPIEN 3 |
| SAVR | Active comparator | Procedure: SAVRSurgical aortic valve replacement |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age must be at least 19 and less than 75 years old
- Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm2. Echocardiogram must be within 3 months of the date of the procedure
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (12 listed)
- Life expectancy <1 year due to medical illness
- Suspected Malignancy
- Inoperability evaluated by surgeon
- Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
- Concomitant severe mitral valve or significant aorta disease requiring surgery
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 |
|---|---|---|
| SAPIEN 3 | Device | TAVR |
| SAVR | Procedure or surgery | SAVR |
Primary outcome
event rate of all-cause mortality
Time frame: 1 year
25 secondary outcomes
event rate of cardiovascular mortality
Time frame: 30 days or hospital discharge, whichever is longer
event rate of cardiovascular mortality
Time frame: 31 days to the 1 year
event rate of myocardial Infarction
Time frame: 30 days or hospital discharge, whichever is longer
event rate of myocardial Infarction
Time frame: 31 days to the 1 year
event rate of all Stroke and transient ischemic attack
Time frame: 30 days or hospital discharge, whichever is longer
event rate of all Stroke and transient ischemic attack
Time frame: 31 days to the 1 year
event rate of bleeding
Time frame: 30 days or hospital discharge, whichever is longer
event rate of bleeding
Time frame: 31 days to the 1 year
event rate of vascular access site and access-related complication
Time frame: 30 days or hospital discharge, whichever is longer
event rate of vascular access site and access-related complication
Time frame: 31 days to the 1 year
event rate of acute kidney injury
Time frame: 30 days or hospital discharge, whichever is longer
event rate of acute kidney injury
Time frame: 31 days to the 1 year
event rate of permanent pacemaker insertion
Time frame: 30 days or hospital discharge, whichever is longer
event rate of permanent pacemaker insertion
Time frame: 31 days to the 1 year
event rate of other TAVR-related complication
Time frame: 30 days or hospital discharge, whichever is longer
event rate of other TAVR-related complication
Time frame: 31 days to the 1 year
event rate of prosthetic valve dysfunction
Time frame: 30 days or hospital discharge, whichever is longer
event rate of prosthetic valve dysfunction
Time frame: 31 days to the 1 year
event rate of composite event for device success, early safety, clinical efficacy
Time frame: 30 days or hospital discharge, whichever is longer
event rate of composite event for device success, early safety, clinical efficacy
Time frame: 31 days to the 1 year
event rate of structural valve deterioration
Time frame: 30 days or hospital discharge, whichever is longer
event rate of structural valve deterioration
Time frame: 31 days to the 1 year
NYHA (New York Heart Association Functional Classification)
Time frame: 30days and 1 year
Valve area
Time frame: 30days and 1 year
event rate of free from atrial fibrillation
Time frame: 30days and 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- 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.
Suck-jung Choo, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SAPIEN 3 and SAVR in people with Aortic Valve Stenosis, 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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 25 Nov 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
event rate of all-cause mortality (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 25 Nov 2016.