An interventional study of INNOVALVE system in Mitral Valve Regurgitation (Degenerative or Functional), sponsored by Edwards Lifesciences. Recruiting at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
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 8th largest by planned enrollment of the 27 interventional ones, is the only one that started in 2022, is one of 26 with no phase, and was the 27th registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 85 is above 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. 1 started in 2022.
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:
Study to evaluate the safety and performance of the INNOVALVE system
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MV replacement with INNOVALVE system
Device: INNOVALVE system
INNOVALVE system
Serious adverse events (SAE) through 30 days post-procedure
Serious adverse events (SAE) through 30 days post-procedure
Time frame: 30 days
Technical success
Time frame: Procedure
Procedural success
Time frame: 30 days
NYHA functional class
Time frame: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Time frame: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12)
Time frame: 30 days, 6, 12 months and annually up to 5 years
Reduction in MR grade
Time frame: 30 days, 6, 12 months and annually up to 5 years
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Started Sep 2022 (actual). Primary completion is estimated for Jul 2028, 70 months after the start.
Of 90 industry-sponsored interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 144. This study's planned 70 months is above that.
Counting every sponsor, half of 143 studies reached it within 56 months; a quarter within 25 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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