The ENCIRCLE Trial

Official title

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Overview

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Detailed description

This is a prospective single-arm, multicenter study.

Interventions

• Device SAPIEN M3 valve and dock
  During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Primary outcome measures

• Non-hierarchical composite of death and heart failure rehospitalization [Time frame: 1 year]

Secondary outcome measures (4)

• Improvement in NYHA functional class compared to baseline [Time frame: 1 year]
• Improvement in KCCQ Overall Score compared to baseline [Time frame: 1 year]
• Improvement in MR compared to baseline [Time frame: 1 year]
• Decrease in LVEDVi compared to baseline [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• 18 years of age or older
• MR ≥ 3+
• NYHA functional class ≥ II
• Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
• Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
• The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

• Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
• Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
• Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
• Left ventricular ejection fraction <25%
• Severe right ventricular dysfunction
• Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
• History of heart transplant
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Active bacterial endocarditis within 180 days of the procedure
• Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
• Myocardial infarction within 30 days of the procedure
• Clinically significant untreated coronary artery disease requiring revascularization
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
• Stroke or transient ischemic attack within 90 days of the procedure
• Irreversible, severe pulmonary hypertension
• Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
• Renal insufficiency or receiving renal replacement therapy
• Liver disease
• Planned surgery within the next 12 months
• Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
• Active infection requiring current antibiotic therapy
• Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• Refusal of blood products
• Female who is pregnant or lactating
• Estimated life expectancy <12 months due to non-cardiac conditions
• Participating in another investigational drug or device study that has not reached its primary endpoint
• Subject considered to be part of a vulnerable population

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 56 centers

• Heart Center Hospital — Huntsville
• Banner University Medical Center — Phoenix
• Saint Josephs Hospital Medical Center Dignity Health — Phoenix
• TMC Healthcare — Tucson
• Scripps Health — La Jolla
• Good Samaritan Hospital — Los Angeles
• Cedars-Sinai Medical Center — Los Angeles
• Kaiser Sunset LA — Los Angeles
• … and 48 more centers

Canada · 3 centers

• Laval University — Québec
• St. Michael's — Toronto
• St. Pauls — Vancouver

Israel · 3 centers

• Shaare Zedek Medical Center — Jerusalem
• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan

Australia · 2 centers

• The Prince Charles Hospital — Chermside
• Royal Prince Alfred Hospital — Camperdown

Netherlands · 2 centers

• Leiden University Medical Center — Leiden
• Rotterdam Erasmus MC — Rotterdam

United Kingdom · 2 centers

• Saint Bartholomew's Medical Center — London
• Saint Thomas Hospital — London

Publications

• Guerrero ME, Daniels DV, Makkar RR, Thourani VH, Asch FM, Pham M, Muhammad KI, Greenbaum AB, Vasquez A, Oldemeyer JB, Dahle TG, Rihal C, Morse MA, Rodriguez E, O'Neill BP, Russo M, Whisenant B, Yadav P, Yu X, Wang DD, Makar M, Baran DA, Mahoney P, Reddy G, Blanke P, Webb J; ENCIRCLE Trial Executive Committee and Study Investigators. Percutaneous transcatheter valve replacement in individuals with PMID 41167201

Identifiers

NCT: NCT04153292 · 2018-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗