UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038202 |
|---|---|
| Receipt number | R000043534 |
| Scientific Title | Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO) |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2023/08/30 12:11:47 |
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Basic information
Public title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)
Acronym
APOLLO Trial
Scientific Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)
Scientific Title:Acronym
APOLLO Trial
Region
| Japan | North America | Europe |
Condition
Condition
Moderate-to-severe or severe symptomatic mitral regurgitation
Classification by specialty
| Cardiology | Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary Cohort: A composite endpoint of all-cause mortality or heart failure hospitalization post 30-days, or KCCQ improvement<10 as evaluated at one year post-implant
MAC Cohort: Composite endpoint of all-cause mortality or heart failure hospitalization at one year in patients with moderate-to-severe or severe symptomatic mitral regurgitation or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC)
The secondary objectives of this trial are to assess quality of life, clinical outcomes (efficacy endpoints) and health economics in patients with moderate-to-severe or severe symptomatic mitral regurgitation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary Cohort: The rate of all-cause mortality, heart failure hospitalization post 30-days, or KCCQ improvement <10 as evaluated at 1 year
MAC Cohort: The rate of all-cause mortality or heart failure hospitalization at 1 year
Key secondary outcomes
1. Composite of all-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), prolonged ventilation, deep wound infection, reoperation or reintervention, or greater than or equal to major bleeding at 30 days or at hospital discharge whichever is longer
2. Change in NYHA at 30 days
3. Change in Quality of Life (QoL) at 30 days (SF-12)
4. Change in Quality of Life (QoL) at 3 months as assessed by KCCQ
5. Degree of mitral regurgitation at 1 year as assessed by Echo Core Lab
6. Cardiovascular hospitalization through 1 year
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Multi-center, global, prospective, interventional, pre-market trial
Enrolled subjects will be assigned to Transcatheter Mitral Valve Replacement (TMVR) with the Medtronic Intrepid TMVR System
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subject has moderate-to-severe or severe symptomatic mitral regurgitation - or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of mitral annular calcification (MAC; for the MAC cohort only)
2. Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Key exclusion criteria
Refer Protocol for details.
1. Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions
2. Currently implanted mitral valve
3. Prior transcatheter mitral valve procedure with device currently implanted
4. Anatomic contraindications for Intrepid TMVR System (e.g., annular dimensions, high risk of LVOT obstruction, system access, etc.
5. Anatomically prohibitive mitral annular calcification (MAC)
6. Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
8. Moderate or greater tricuspid regurgitation with echocardiographic evidence of significantly impaired right ventricular function as assessed by the echo core lab
12. Left ventricular ejection fraction (LVEF) <30% measured by resting transthoracic echocardiogram
14. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than dilated ischemic or non-ischemic cardiomyopathy
17. Need for emergent or urgent cardiac or non-cardiac surgery
18. Hemodynamic instability requiring dependency of either inotropic agents or mechanical circulatory support
26. Untreated clinically significant coronary artery disease requiring revascularization
32. End stage renal disease requiring chronic dialysis or creatinine clearance < 45 cc/min within 30 days of the Index Procedure
33. Liver failure (Child-Pugh-C)
34. Any Cancer requiring active treatment or with life expectancy less than 24 months
35. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced
Expiratory Volume (FEV1) < 750cc, continuous home oxygen therapy, or chronic outpatient oral steroid use
36. Frailty assessments
39. Severe dementia
Target sample size
1350
Research contact person
Name of lead principal investigator
| 1st name | Koyo |
| Middle name | |
| Last name | Sakaguchi |
Organization
OU Clinical
Division name
OU Clinical
Zip code
108-0075
Address
1-2-70 Konan , Minato-ku, Tokyo
TEL
080-4333-9376
koyo.sakaguchi@medtronic.com
Public contact
Name of contact person
| 1st name | Koyo |
| Middle name | |
| Last name | Sakaguchi |
Organization
OU Clinical
Division name
OU Clinical
Zip code
108-0075
Address
1-2-70 Konan , Minato-ku, Tokyo
TEL
080-4333-9376
Homepage URL
koyo.sakaguchi@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-15 Yamadaoka, Suita-shi, Osaka 565-0871
Tel
06-6879-5111
jim-chiken@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院 (大阪府) Osaka University
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043534
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| Registered date | File name |
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| Registered date | File name |
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