Mitral Valve RegurgitationPRELUDENCT02768402
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
A study testing Caisson TMVR System in people with Mitral Valve Regurgitation, run by Caisson Interventional LLC at 13 sites in United States.
Trial summary
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Caisson TMVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2016to Dec 2023
- 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
- Has severe mitral regurgitation
- New York Heart Association (NYHA) Class II, III, IVa or heart failure
- High risk for cardiovascular surgery
Who cannot join
- Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
- Left ventricular end diastolic dimension > 7cm
- Left ventricular outflow tract obstruction
- Severe right ventricular dysfunction
- Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
OhioHealth
Columbus, Ohio, 43214
Delray Medical Center
Delray Beach, Florida, 33484
Cedars Sinai Medical Center
Los Angeles, California, 90048
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Morristown Medical Center
Morristown, New Jersey, 07962
Saint Thomas Heart
Nashville, Tennessee, 37205
New York University Langone Medical Center
New York, New York, 10016
Mayo Clinic
Rochester, Minnesota, 55902
Swedish Health Services
Seattle, Washington, 98122
University of Washington
Seattle, Washington, 98195
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
Read the detailed description
The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Caisson TMVR System
- Keywords
- Mitral Valve Regurgitation, Primary MR, Secondary MR, MR, Heart Failure, Structural Heart, Secondary Mitral Valve Regurgitation, Primary Mitral Valve Regurgitation, Transseptal, Transcatheter
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caisson TMVR SystemDevice
Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study. Receives: Device: Caisson TMVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without Major Adverse Events (MAEs)
Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days
Measured: 30 days
Secondary outcomes (2)
Number of patients with successful delivery and implantation of the prosthetic valve (technical success)
Successful delivery and retrieval of the transcatheter mitral valve delivery system; deployment and correct positioning (via intraoperative imaging) in the appropriate anatomic location of prosthetic valve with no requirement for additional surgery
Measured: Intraoperative
Number of living, stroke-free patients with prosthetic valve in place (device success)
Patient is alive, stroke-free, original intended device in place (echo), no mitral valve surgical re-intervention required
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- Caisson Interventional LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Williams, MD, Study director, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768402
- Sponsor's protocol ID
- 001
- Acronym
- PRELUDE
- Status last verified
- Jan 2020
- First submitted
- 5 May 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
- ClinicalTrials.gov ID
- NCT02768402
- Acronym / sponsor ID
- PRELUDE / 001
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral Valve Regurgitation, Primary MR, Secondary MR, MR, Heart Failure, Structural Heart, Secondary Mitral Valve Regurgitation, Primary Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Caisson Interventional LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 May 2016 (estimated)
- 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.
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
Detailed description
The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Caisson TMVR SystemAll eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has severe mitral regurgitation
- New York Heart Association (NYHA) Class II, III, IVa or heart failure
- High risk for cardiovascular surgery
Key exclusion criteria (5 listed)
- Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
- Left ventricular end diastolic dimension > 7cm
- Left ventricular outflow tract obstruction
- Severe right ventricular dysfunction
- Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure
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 |
|---|---|---|
| Caisson TMVR SystemTranscatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation. | Device | Treatment Arm |
Primary outcome
Number of patients without Major Adverse Events (MAEs)
Time frame: 30 days
Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days
2 secondary outcomes
Number of patients with successful delivery and implantation of the prosthetic valve (technical success)
Time frame: Intraoperative
Number of living, stroke-free patients with prosthetic valve in place (device success)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Regurgitation
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
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The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
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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.
Mathew Williams, MD study director
NYU Langone Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caisson TMVR System in people with Mitral Valve Regurgitation, run by Caisson Interventional LLC at 13 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 3 inclusion and 5 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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?
Number of patients without Major Adverse Events (MAEs) (time frame: 30 days). 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 28 Jan 2020.