Mitral RegurgitationNCT03539458
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
A study testing Tendyne Mitral Valve System in people with Mitral Regurgitation and Mitral Insufficiency, run by Abbott Medical Devices at 4 sites in United States.
Trial summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification
- What is being tested?
- Tendyne Mitral Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Oct 2018to 18 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation
- Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
- NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
- Age 18 years or older at time of consent
- Not a member of a vulnerable population per the investigator's judgment
- The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent
Who cannot join
- Presence of Left Ventricle or Left Atrium thrombus
- Chest condition that prevents transapical access
- Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
- Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm
- Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
- Prior intervention with permanently implanted mitral device (e.g. MitraClip)
Show all 30Show fewer
- Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation
- Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure
- Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure
- Myocardial Infarction (MI) within 30 days of the planned implant procedure
- Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG
- Cerebrovascular accident (CVA) within six months of planned implant procedure
- Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
- Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure
- Severe tricuspid regurgitation or severe right ventricular dysfunction
- Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated
- History of endocarditis within 6 months of planned implant procedure
- Active systemic infection requiring antibiotic therapy
- Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically
- Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation
- Known hypersensitivity to nickel or titanium
- Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD)
- Subject has pulmonary arterial hypertension (fixed PAS >70mmHg)
- FEV1 < 50% of predicted or < 1L
- Subject refuses blood transfusions
- Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- Pregnant, lactating, or planning pregnancy within next 12 months.
- Currently participating in an investigational drug or another device trial that has not reached its primary endpoint
- Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital
Atlanta, Georgia, 30322
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26506
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
About this study
Official title: Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification, Cardiovascular Diseases, Valve Heart Disease
- Being tested
- Tendyne Mitral Valve System
- Medical subject headings
- Mitral Valve Insufficiency, Cardiovascular Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendyne Mitral Valve SystemDevice
Mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | All subjects will undergo procedure with the Tendyne Mitral Valve System. Receives: Device: Tendyne Mitral Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
Definition of Device Success:
All of the following must be present:
- Absence of procedural mortality or stroke; and
- Proper placement and positioning of the device, and
- Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
- Continued intended safety and performance of the device, including:
- No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis).
All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee
Measured: 30 days post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start10 Oct 2018
- Primary completion29 Nov 2019
- Study completion18 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Sorajja, MD, Principal investigator, Minneapolis Heart Institute - Abbott Northwestern HospitalVinod Thourani, MD, Principal investigator, Piedmont Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539458
- Sponsor's protocol ID
- CS0005-P
- Status last verified
- Oct 2024
- First submitted
- 12 Apr 2018
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
- ClinicalTrials.gov ID
- NCT03539458
- Acronym / sponsor ID
- CS0005-P
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification, Cardiovascular Diseases, Valve Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 26 Jan 2021
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 Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Tendyne Mitral Valve SystemAll subjects will undergo procedure with the Tendyne Mitral Valve System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation
- Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
- NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
- Age 18 years or older at time of consent
- Not a member of a vulnerable population per the investigator's judgment
Key exclusion criteria (30 listed)
- Presence of Left Ventricle or Left Atrium thrombus
- Chest condition that prevents transapical access
- Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
- Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm
- Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
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 |
|---|---|---|
| Tendyne Mitral Valve SystemMitral valve replacement | Device | Device Arm |
Primary outcome
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
Time frame: 30 days post implant
Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Paul Sorajja, MD principal investigator
Minneapolis Heart Institute - Abbott Northwestern Hospital
Vinod Thourani, MD principal investigator
Piedmont Heart Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendyne Mitral Valve System in people with Mitral Regurgitation and Mitral Insufficiency, run by Abbott Medical Devices at 4 sites in United States.
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 6 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 26 Jan 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?
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC) (time frame: 30 days post implant). 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 18 Nov 2024.