---
title: "ENCIRCLE Trial Wins FDA Nod for New Heart Valve Fix | Sutter Health"
description: "Sutter cardiologist Dr. David Daniels led the global ENCIRCLE trial, published in The Lancet, leading to FDA approval of a new valve treatment."
url: "https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation"
---

1.  [Home](https://vitals.sutterhealth.org/) /
2.  [Media resources](https://vitals.sutterhealth.org/media-resources) /
3.  [Press releases](https://vitals.sutterhealth.org/media-resources/press-releases) /
4.  Encircle Trial Transforms Treatment Of Mitral Regurgitation

# ENCIRCLE Trial Leads to FDA Approval of a New Treatment for Mitral Regurgitation

Sutter cardiologist Dr. David Daniels led the global ENCIRCLE trial, published in The Lancet, leading to FDA approval of a new valve treatment.

October 28, 2025 by Sutter Health

![ENCIRCLE Trial Leads to FDA Approval of a New Treatment for Mitral Regurgitation](https://edge.sitecorecloud.io/sutterhealt962c-sutterhealt8fce-production57cc-4860/media/Project/SutterHealth/Vitals/press-releases/Untitled-design-1-3394e4be.jpg?h=788&iar=0&w=940 "ENCIRCLE Trial Leads to FDA Approval of a New Treatment for Mitral Regurgitation")

_Sutter Health Cardiologist and Global PI Presents Findings Published in The Lancet_

NORTHERN CALIF.– [Dr. David Daniels](http://sutterhealth.org/find-provider/dr-david-daniels-1046234487), an interventional cardiologist with Sutter West Bay Medical Group and structural heart section chief of Sutter’s Advanced Heart & Vascular Service Line, presented pivotal, late-breaking results of the international ENCIRCLE Clinical Trial yesterday at the [Transcatheter Cardiovascular Therapeutics](https://www.tctconference.com/) conference in San Francisco.

The findings were simultaneously published in [The Lancet](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(25\)02073-2/abstract).

![Male doctor with brown hair smiling in head shot](https://edge.sitecorecloud.io/sutterhealt962c-sutterhealt8fce-production57cc-4860/media/Project/SutterHealth/Vitals/research-and-innovation/dave-daniels-150x150-501bee35.jpg "Dr. David Daniels")

“On behalf of ENCIRCLE investigators, I’m proud to share the results of our study which will transform care for mitral regurgitation: for patients with severe mitral regurgitation who previously had no viable surgical or transcatheter option, the SAPIEN M3 system not only significantly reduced regurgitation severity but also improved heart failure symptoms and quality of life. This is a groundbreaking step in heart and vascular medicine —giving hope and a new therapeutic option for high‑risk patients who until now were left without a definitive treatment option,” said Dr. Daniels.

**More on ENCIRCLE**

ENCIRCLE, a multicenter pivotal study demonstrated Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system effectively reduced mitral regurgitation with low rates of complications and mortality.

[In December 2025](https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.edwards.com%2Fnewsroom%2Fnews%2F2025-12-23-fda-approves-edwards-lifesciences--sapien-m3-mitra&data=05%7C02%7CJulia.Jones%40sutterhealth.org%7C477d680beab24b89258408de4318091f%7Caef453eadaa243e0be62818066e9ff63%7C0%7C0%7C639021967691404775%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=BbTtvhFzJjWl1ik2zduXt5K375tLw3u2JxpL5%2F7kHUE%3D&reserved=0), the U.S. Food and Drug Administration approved the SAPIEN M3 system, the first transseptal, catheter-based mitral valve replacement therapy cleared in the United States for the treatment of mitral regurgitation. The approval was supported by data from the ENCIRCLE trial and expands treatment options for patients who are not candidates for surgery or transcatheter edge-to-edge repair.

A total of 1,171 patients were screened at 56 sites in the United States, Canada, Europe, Israel and Australia. Thirty-five percent of those screened were excluded based on anatomic eligibility criteria. Ultimately, 299 patients with MR ≥3+ and NYHA Class ≥II who were unsuitable for surgery or commercially available transcatheter treatment options due to clinical, anatomic or technical considerations were treated. Of these, 287 patients had a SAPIEN M3 replacement valve implanted.

The primary endpoint was the composite of all-cause mortality and rehospitalization for heart failure at one year compared to a pre-specified performance goal of 45%. After one year, the composite event rate was 25.2% (95% CI: 20.6-30.6; p <0.0001). All-cause death and heart failure hospitalization rates were 13.9% and 16.7%, respectively.

Patients also showed major gains in daily functioning and quality of life. More than 95% had little-to-no valve leakage at both 30 days and one year. Nearly three-quarters had improved heart function at one year, and almost nine in 10 were able to perform daily activities with fewer symptoms.

Rates of stroke, clinically significant leaflet thrombosis and hemolysis were 9.3%, 6.7% and 7.1%, respectively at one year.

“Percutaneous transseptal TMVR had a low mortality rate while providing a significant reduction in mitral regurgitation severity and meaningful and durable improvements in functional status and quality of life,” said Dr. Daniels. “These findings will help guide clinical practice by providing an alternative treatment option for patients who are unsuitable for conventional surgery or transcatheter edge-to-edge repair procedures.”

**Research at Sutter Advances New Level of Clinically Excellent, Advanced Heart & Vascular Care** 

With one of the largest heart and vascular clinical trials programs on the U.S. West Coast, Sutter — a leading health system providing the latest clinical advances to patients across California — is using research to help expand life-saving possibilities and deliver new solutions to address unmet clinical needs, including in patients with mitral regurgitation.

Minimally invasive techniques offered across Sutter’s integrated, not-for-profit system, including robotic-assisted valve repair and replacement, are revolutionizing care — extending lives, reducing hospital stays and making high-quality care more accessible across the communities it serves.

“Dr. Daniels’ leadership on a national stage shows how Sutter is redefining the future of heart and vascular care, building on more than a century of research and innovation to expand lifesaving possibilities for our patients,” said Warner Thomas, president and CEO of Sutter Health. “Through pioneering clinical trials like ENCIRCLE, we are at the forefront of advancing critical, minimally invasive solutions for valvular heart disease, offering new hope to those who had few or no treatment options. These breakthroughs reflect our commitment to clinical excellence powered by cutting-edge science.”

## Topics

[Heart Disease](https://vitals.sutterhealth.org/search?facets=%5B%7B%22i%22%3A%22c_healthTopics.name%22%2C%22v%22%3A%5B%22Heart+Disease%22%5D%7D%5D&verticalKey=articles)

## Heart valve disease

Healthy heart valves keep your blood flowing in the right direction. If you're experiencing valve disease symptoms like shortness of breath or fatigue, our specialists can provide diagnosis and treatments to protect your heart.

[Learn more about Heart valve disease](https://www.sutterhealth.org/services/heart-valve-disease)

## Related articles

### [Sutter Team Among First to Use New TMVR Therapy](https://vitals.sutterhealth.org/research-innovation/sutter-team-among-first-to-use-new-tmvr-therapy)

### [Small Device, Big Impact: Research Brings New Hope for Failing Hearts](https://vitals.sutterhealth.org/research-innovation/small-device-big-impact-research-brings-new-hope-for-failing-hearts)

### [Heart Care Heavyweights: 6 Ways Doctors Flex Their Muscles to Treat Yours](https://vitals.sutterhealth.org/research-innovation/breakthroughs-in-cardiovascular)

### [Change of Heart: Sutter Health is Poised for New Era in Cardiology Care](https://vitals.sutterhealth.org/research-innovation/change-heart-sutter-health-poised-new-era-cardiology-care)

[See all from Press releases](https://vitals.sutterhealth.org/media-resources/press-releases)

## Check your Vitals

Get the latest in health innovation, community impact and patient care from Sutter Health — delivered straight to your inbox.

[Subscribe to Vitals](https://vitals.sutterhealth.org/subscribe)

```json
{"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]}
```

```json
{"@context":"https://schema.org","@type":"WebPage","name":"ENCIRCLE Trial Wins FDA Nod for New Heart Valve Fix","description":"Sutter cardiologist Dr. David Daniels led the global ENCIRCLE trial, published in The Lancet, leading to FDA approval of a new valve treatment.","url":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation","breadcrumb":{"@id":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation#breadcrumblist"}}
```

```json
{"@context":"https://schema.org","@type":"Article","@id":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation#article","url":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation","headline":"ENCIRCLE Trial Wins FDA Nod for New Heart Valve Fix","description":"Sutter cardiologist Dr. David Daniels led the global ENCIRCLE trial, published in The Lancet, leading to FDA approval of a new valve treatment.","articleSection":"Press releases","inLanguage":"en-US","datePublished":"2025-10-28T07:16:51-07:00","dateModified":"2026-11-02T19:46:28-08:00","author":[{"@context":"https://schema.org","@type":"Person","name":"Sutter Health"}],"publisher":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"},"abstract":"Sutter cardiologist Dr. David Daniels led the global ENCIRCLE trial, published in The Lancet, leading to FDA approval of a new valve treatment.","image":{"@type":"ImageObject","url":"https://edge.sitecorecloud.io/sutterhealt962c-sutterhealt8fce-production57cc-4860/media/Project/SutterHealth/Vitals/press-releases/Untitled-design-1-3394e4be.jpg?h=788&iar=0&w=940","width":"940","height":"788","caption":"ENCIRCLE Trial Leads to FDA Approval of a New Treatment for Mitral Regurgitation"},"thumbnailUrl":"https://edge.sitecorecloud.io/sutterhealt962c-sutterhealt8fce-production57cc-4860/media/Project/SutterHealth/Vitals/press-releases/Untitled-design-1-3394e4be.jpg?h=788&iar=0&w=940","isPartOf":{"@type":"WebSite","@id":"https://vitals.sutterhealth.org/#website","name":"Vitals - Sutter Health","url":"https://vitals.sutterhealth.org"},"mainEntityOfPage":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation","about":[{"@type":"Thing","name":"Heart valve disease"},{"@type":"Thing","name":"Interventional cardiology"}],"keywords":["Heart Disease"]}
```

```json
{"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://vitals.sutterhealth.org/media-resources/press-releases/encircle-trial-transforms-treatment-of-mitral-regurgitation#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://vitals.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Media resources","item":"https://vitals.sutterhealth.org/media-resources"},{"@type":"ListItem","position":3,"name":"Press releases","item":"https://vitals.sutterhealth.org/media-resources/press-releases"},{"@type":"ListItem","position":4,"name":"Encircle Trial Transforms Treatment Of Mitral Regurgitation"}]}
```