Mitral RegurgitationNCT04464876
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
A study testing SATURN TA System in people with Mitral Regurgitation and Valve Heart Disease, run by InnovHeart at 3 sites in 3 countries.
Trial summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Valve Heart Disease, Heart Valve Diseases
- What is being tested?
- SATURN TA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Aug 2020to Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Severe functional mitral regurgitation (≥ Grade 3+).
- NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
- Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
- Able to complete quality-of-life assessment (KCCQ).
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- General Exclusion Criteria:
- Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
- Life expectancy <1 yr due to noncardiac conditions.
- Active endocarditis.
- Active systemic infection.
- Modified Rankin Scale ≥4 disability.
- Hemodialysis/ chronic renal failure (eGFR < 35 mL/min/m2).
- Pulmonary arterial hypertension (fixed PAS < 60mmHg). 8) COPD on home oxygen.
- 9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
- 11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- 12) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
- 13) Participating in other investigational studies likely to confound the results or affect the study.
- 14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".
- Cardiovascular Exclusion Criteria:
- Myocardial infarction during prior 30 days.
- Stroke or TIA during prior 30 days.
- Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
- Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
- Prior surgical mechanical valve AVR.
- Prior TAVI.
- Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days.
- CRT or ICD implanted in previous 30 days.
- Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
- CABG or PCI within previous 30 days.
- Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization.
- Prior or planned heart transplantation (UNOS status 1).
- Physical evidence of right-sided congestive heart failure:
- Patients with ascites.
- Patients with anasarca (generalized edema / hydropsy).
- Procedural Exclusion Criteria:
- Chest condition that prevents transapical access.
- Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
- Documented hypersensitivity to nickel or titanium.
- Cardiac Exclusion Criteria (evaluated by Core Labs):
- Left ventricular EF ≤ 30% by imaging.
- Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- Extensive mitral flail leaflets.
- Left ventricular thrombus, mass, or vegetation.
- Left ventricular end-diastolic diameter > 7.5 cm.
- Severe right ventricular dysfunction.
- Significant intracardiac shunt.
- Anatomic ineligibility for SATURN valve as determined by the Screening Committee.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.
- Conditions
- Mitral Regurgitation, Valve Heart Disease, Heart Valve Diseases, Mitral Valve Disease, Mitral Disease
- Being tested
- SATURN TA System
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SATURN TA SystemDevice
SATURN TA TMVR Device implanted
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | SATURN TA TMVR Device implanted Receives: Device: SATURN TA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device-related or procedure-related major adverse events
Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
Measured: 30 days
Reduction of mitral regurgitation
Reduction of mitral regurgitation to ≤1 at 30 days.
Measured: 30 days
Technical success
Technical success defined as alive patient at exit from procedure room, with all of the following:
- Successful access, delivery and retrieval of the delivery systems.
- Development and correct positioning of the bioprosthesis.
- Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
Measured: Day 0
Secondary outcomes (7)
Freedom from device-related or procedure-related major adverse events
- Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.
- Freedom from all-cause mortality
Measured: 30 days, 1 year, 2 years
Freedom from all-cause mortality
Freedom from all-cause mortality
Measured: 30 days, 1 year, 2 years
Patients success
Patients success
Measured: 30 days, 1 year, 2 years
Device success
Device success
Measured: 30 days, 1 year, 2 years
6 Minute Hall Walk Test
Improvement from baseline in functional status by ≥ 30 meters
Measured: 30 days, 1 year, 2 years
KCCQ
Improvement from baseline in Quality of Life by ≥ 10 points.
Measured: 30 days, 1 year, 2 years
NYHA functional classification
Improvement from baseline by ≥ 1 functional classification.
Measured: 30 days, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start19 Aug 2020
- Primary completion30 Sep 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie Steinbrink, Study director, InnovHeart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464876
- Sponsor's protocol ID
- TP-0050
- Status last verified
- Jan 2024
- First submitted
- 24 Jun 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT04464876
- Acronym / sponsor ID
- TP-0050
- Conditions
- Mitral Regurgitation, Valve Heart Disease, Heart Valve Diseases, Mitral Valve Disease, Mitral Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- InnovHeartIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jul 2020 (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 a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: SATURN TA SystemSATURN TA TMVR Device implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Age 18 years or older.
- Severe functional mitral regurgitation (≥ Grade 3+).
- NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
- Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SATURN TA SystemSATURN TA TMVR Device implanted | Device | Treatment |
Primary outcome
Freedom from device-related or procedure-related major adverse events
Time frame: 30 days
Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
Reduction of mitral regurgitation
Time frame: 30 days
Reduction of mitral regurgitation to ≤1 at 30 days.
Technical success
Time frame: Day 0
Technical success defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the delivery systems. * Development and correct positioning of the bioprosthesis. * Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
7 secondary outcomes
Freedom from device-related or procedure-related major adverse events
Time frame: 30 days, 1 year, 2 years
Freedom from all-cause mortality
Time frame: 30 days, 1 year, 2 years
Patients success
Time frame: 30 days, 1 year, 2 years
Device success
Time frame: 30 days, 1 year, 2 years
6 Minute Hall Walk Test
Time frame: 30 days, 1 year, 2 years
KCCQ
Time frame: 30 days, 1 year, 2 years
NYHA functional classification
Time frame: 30 days, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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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.
Marie Steinbrink study director
InnovHeart
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SATURN TA System in people with Mitral Regurgitation and Valve Heart Disease, run by InnovHeart at 3 sites in 3 countries.
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 48 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Hungary, Lithuania. 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?
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?
Freedom from device-related or procedure-related major adverse events (time frame: 30 days). 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 22 May 2024.