An interventional study of Harpoon Artificial ePTFE Chords in Mitral Valve Regurgitation, Mitral Valve Prolapse and Mitral Valve Insufficiency, sponsored by Edwards Lifesciences. Terminated at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
Among 32 studies in Mitral Valve Insufficiency by Edwards Lifesciences — 2 open to participants now, 10 under way, none of them phase 3. Mitral Valve Insufficiency · Edwards Lifesciences.
Among the 32 studies in Mitral Valve Insufficiency by Edwards Lifesciences, this one is the 24th largest by enrollment of the 27 interventional ones, is one of 4 that started in 2017, is one of 26 with no phase, and was the 18th registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's enrollment of 1 is below the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →2 of the 32 studies in Mitral Valve Insufficiency by Edwards Lifesciences are open now, in 1 country. Each count lists the studies.
Of the 122 Mitral Valve Insufficiency studies recruiting now, 101 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2017.
Median enrollment 26 across the 27 interventional studies, 220 across the 5 observational. Of the 19 that completed or were terminated, 13 (68%) have results posted.
Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.
1 of the studies in Mitral Valve Insufficiency by Edwards Lifesciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04153292Edwards LifesciencesThe ENCIRCLE Trial | 2027-10-10 |
Among the 32 studies in Mitral Valve Insufficiency by Edwards Lifesciences, from their registry updates:
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.
Device: Harpoon Artificial ePTFE Chords
The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.
Number of Subjects With Procedural Success During the First 30 Days
To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
Time frame: Procedure, discharge, and 30 days
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
Time frame: Procedure, Discharge and 30 Days
Subject's Severity of Mitral Regurgitation Over Time
Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
Subject's Freedom From Serious Adverse Events Over Time
Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
| Milestone | Harpoon Medical Device |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
| Participants | Harpoon Medical Device |
|---|---|
| Procedure | 0 |
| Discharge | 0 |
| 30 days follow-up | 0 |
Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
| Participants | Harpoon Medical Device |
|---|---|
| Procedure | 0 |
| Discharge | 0 |
| 30 Days | 0 |
Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
No measurements were reported for this outcome.
Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
No measurements were reported for this outcome.
Collected over Events occurring from baseline through end of procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Harpoon Medical Device | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Event | Harpoon Medical Device |
|---|---|
| Implantation cord failure, mitral ring damageCardiac disorders | 1/1 |
| Age, Customized(years) | Harpoon Medical Device |
|---|---|
| Age | 70 |
| Sex: Female, Male(Participants) | Harpoon Medical Device |
|---|---|
| Female | 1 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Harpoon Medical Device |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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