Aortic StenosisNCT02686814
PERIGON Japan Trial
A study testing 17mm MDT-2215 aortic valve bioprosthesis in people with Aortic Stenosis, run by Medtronic Cardiac Surgery at 10 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- 17mm MDT-2215 aortic valve bioprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesJapan
- Study dates
- Mar 2016to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has severe aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
- Left atrial appendage (LAA) ligation
- Coronary artery bypass graft (CABG)
- Patent foramen ovale (PFO) closure
- Ascending aortic aneurysm or dissection repair not requiring circulatory arrest
- Resection of a sub-aortic membrane not requiring myectomy
Show all 10Show fewer
- Patient is geographically stable and willing to return to the implanting site for all follow-up visits
- Patient is of legal age to provide informed consent
- Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
- In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve
Who cannot join
- Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
- Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis
- Patient presents with active endocarditis, active myocarditis or other systemic infection
- Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
- Ascending aortic aneurysm or dissection repair requiring circulatory arrest
- Acute type A aortic dissection
Show all 30Show fewer
- Ventricular aneurysm
- Porcelain aorta
- Hostile mediastinum
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Documented pulmonary hypertension (systolic >60mmHg)
- Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
- Child-Pugh Class C liver disease
- Terminal cancer
- End-stage lung disease
- Patient has renal failure, defined as dialysis therapy or glomerular filtration rate (GFR)<30 mL/min/1.73 m2
- Patient has hyperparathyroidism
- Patient is participating in another investigational device or drug trial or observational competitive study
- Patient is pregnant, lactating or planning to become pregnant
- Patient has a documented history of substance (drug or alcohol) abuse
- Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
- Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
- Patient has grade IV diastolic dysfunction
- Patient has documented bleeding diatheses
- Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
- Patient requires emergency surgery
- Patient is in NYHA Class I
- Operative Exclusion Criteria:
- 1.) Prior to attempted implant of MDT-2215 valve, it is identified the patient requires a concomitant procedure not allow per the enrollment exclusion criteria
- 2.) Patient anatomy is not suitable for implant of a size 17mm MDT-2215 aortic valve bioprosthesis
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Chiba-Nishi General Hospital
Chiba, 270-2251
Kobe University Hospital
Hyogo Prefecture, 650-0017
Hyogo Prefectural Harima-Himeji General Medical Center
Hyogo Prefecture, 670-8560
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kurashiki Central Hospital
Okayama, 710-8602
National Cerebral and Cardiovascular Center
Osaka, 564-8565
Saitama Medical Center, Jichi Medical University
Saitama, 330-8503
Saitama Medical University International Medical Center
Saitama, 350-1298
Tokushima Red Cross Hospital
Tokushima, 773-8502
Sakakibara Heart Institute
Tokyo, 183-0003
About this study
Official title: A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the 17mm MDT-2215 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
Read the detailed description
This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.
This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)
- Conditions
- Aortic Stenosis
- Being tested
- 17mm MDT-2215 aortic valve bioprosthesis
- Keywords
- Valvular heart disease, Severe aortic stenosis, Aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17mm MDT-2215 aortic valve bioprosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| MDT-2215 | Experimental | 17mm MDT-2215 aortic valve bioprosthesis Receives: Device: 17mm MDT-2215 aortic valve bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated.
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: This outcome will be identified from measurement at baseline and 1 year.
Effective Orifice Area Index at Baseline and 1 Year Post-procedure
Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2
Measured: This outcome will be measured at 1 year.
Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year
Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm^2/m^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI.
See Objective 1 for NYHA definition See Objective 2 for EOAI definition
Measured: This outcome will be identified from measurement at baseline and 1 year.
Secondary outcomes (14)
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Measure Description: Cardiac Disease with Functional Classes I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm^2) per unit body surface area (m^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2.
Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2
Measured: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Effective Orifice Area (cm^2) From Baseline up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Performance Index (L/Min) From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Output (L/Min) From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Safety:Valve-related Adverse Events
The early (<=30days post-procedure), late (>30days post-procedure) and 1-year participant counts of the following valve-related adverse events will be evaluated:
- thromboembolism
- thrombosis
- hemorrhage
- paravalvular leak
- endocarditis
- hemolysis
- structural valve deterioration
- non-structural dysfunction
- reintervention
- explant
- death
Measured: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life.
Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71
Measured: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life.
Lowest possible score: 31.63 Highest possible score: 66.69
Measured: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Yutaka Okita, MD, Principal investigator, Kobe University Hospital, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686814
- Sponsor's protocol ID
- MDT-2215
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2015
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the 17mm MDT-2215 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT02686814
- Acronym / sponsor ID
- MDT-2215
- Conditions
- Aortic Stenosis
- Keywords
- Valvular heart disease, Severe aortic stenosis, Aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 12 Apr 2024
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 evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
Detailed description
This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.
This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDT-2215 | Experimental | Device: 17mm MDT-2215 aortic valve bioprosthesis17mm MDT-2215 aortic valve bioprosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patient has severe aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
- Patient is geographically stable and willing to return to the implanting site for all follow-up visits
- Patient is of legal age to provide informed consent
- Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
- In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve
Key exclusion criteria (30 listed)
- Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
- Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis
- Patient presents with active endocarditis, active myocarditis or other systemic infection
- Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
- Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
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 |
|---|---|---|
| 17mm MDT-2215 aortic valve bioprosthesis | Device | MDT-2215 |
Primary outcome
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
Time frame: This outcome will be identified from measurement at baseline and 1 year.
Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Effective Orifice Area Index at Baseline and 1 Year Post-procedure
Time frame: This outcome will be measured at 1 year.
Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2
Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year
Time frame: This outcome will be identified from measurement at baseline and 1 year.
Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm^2/m^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition
14 secondary outcomes
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Time frame: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
Time frame: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Effective Orifice Area (cm^2) From Baseline up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Performance Index (L/Min) From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Output (L/Min) From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Safety:Valve-related Adverse Events
Time frame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
Time frame: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
Time frame: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yutaka Okita, MD principal investigator
Kobe University Hospital, Japan
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17mm MDT-2215 aortic valve bioprosthesis in people with Aortic Stenosis, run by Medtronic Cardiac Surgery at 10 sites in Japan.
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 10 inclusion and 30 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure (time frame: This outcome will be identified from measurement at baseline and 1 year.). The study lists 3 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 12 Apr 2024.