Mitral RegurgitationMitraClip NTNCT03500692
MitraClip NT System Post-marketing Surveillance Study - Japan
An observational study of Mitral Regurgitation and Mitral Valve Regurgitation, run by Abbott Medical Devices at 40 sites in Japan.
Trial summary
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Regurgitation
- What is being tested?
- MitraClip NT System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 40 sitesJapan
- Study dates
- 2 Apr 2018to 23 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-marketing Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted.
Inclusion Criteria: Refer to MitraClip IFU
Exclusion Criteria: Refer to MitraClip IFU
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431
The University of Tokyo Hospital
Bunkyo, Tokyo, 113-8655
Mitsui Memorial Hospital
Chiyoda City, Tokyo, 101-8643
Sakakibara Heart Institute
Fuchū, Tokyo, 183-0003
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Hyogo Brain and Heart Center
Himeji, Hyōgo, 670-0981
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
St. Marianna Medical University Hospital
Kawasaki, Kanagawa, 216-8511
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
New Tokyo Hospital
Matsudo, Chiba, 270-2232
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-0834
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Nagoya Heart Center
Nagoya, Aichi-ken, 461-0045
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, 700-0804
Osaka City University Hospital
Osaka, Osaka, 545-8586
Osaka General Medical Center
Osaka, Osaka, 558-8558
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666
Shizuoka General Hospital
Shizuoka, Shizuoka, 420-8527
Osaka University Hospital
Suita-shi, Osaka, 565-0871
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, 565-8565
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
Tokushima Red Cross Hospital
Tokushima, 773-8502
Toyama University Hospital
Toyama, Toyama, 930-0194
Toyohashi Heart Center
Toyohashi, Aichi-ken, 441-8530
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, 279-0001
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 230-8765
Tottori University Hospital
Yonago, Tottori, 683-8504
About this study
Official title: MitraClip NT System Post -Marketing Surveillance Study
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Read the detailed description
This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.
Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation
- Being tested
- MitraClip NT System
- Keywords
- Mitral Valve Regurgitation, MitraClip, MitraClip NT, Japan MitraClip NT Postmarketing Surveillance
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip NT SystemDevice
Percutaneous mitral valve repair using MitraClip NT System
| Study group | Role | What they receive |
|---|---|---|
| MitraClip NT System | Percutaneous mitral valve repair using MitraClip NT System Receives: Device: MitraClip NT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Leaflet Device Attachment (SLDA) Rate
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Measured: up to 30 Days
No of Participants With Acute Procedural Success (APS)
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment.
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Measured: up to 7 days (Discharge visit) from Procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start2 Apr 2018
- Primary completion31 Mar 2019
- Study completion23 Mar 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 Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500692
- Sponsor's protocol ID
- 17-519
- Acronym
- MitraClip NT
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2018
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitraClip NT System Post -Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT03500692
- Acronym / sponsor ID
- MitraClip NT / 17-519
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation
- Keywords
- Mitral Valve Regurgitation, MitraClip, MitraClip NT, Japan MitraClip NT Postmarketing Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 15 Apr 2021
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 the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Detailed description
This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.
Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip NT System | – | Device: MitraClip NT SystemPercutaneous mitral valve repair using MitraClip NT System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-marketing Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted.
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 |
|---|---|---|
| MitraClip NT SystemPercutaneous mitral valve repair using MitraClip NT System | Device | MitraClip NT System |
Primary outcome
Single Leaflet Device Attachment (SLDA) Rate
Time frame: up to 30 Days
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
No of Participants With Acute Procedural Success (APS)
Time frame: up to 7 days (Discharge visit) from Procedure date
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Mitral Valve Regurgitation, run by Abbott Medical Devices at 40 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?
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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 15 Apr 2021). 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?
Single Leaflet Device Attachment (SLDA) Rate (time frame: up to 30 Days). The study lists 2 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 23 Jul 2024.