COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Overview

About this study

The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Weight ≥ 20 kg (44 lbs.)

2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with
a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and
≤ 29 mm immediately prior to study device insertion as per the Instructions for Use

3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.

4. The subject/subject's legally authorized representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent.

Exclusion Criteria:

1. Active infection requiring current antibiotic therapy (if temporary illness, subject
may be a candidate 2 weeks after discontinuation of antibiotics)

2. History of or active endocarditis (active treatment with antibiotics) within the past
180 days

3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder

4. Inappropriate anatomy for femoral introduction and delivery of the study valve

5. Need for concomitant atrial septal defect or ventricular septal defect closure or
other concomitant interventional procedures other than pulmonary artery or branch
pulmonary artery stenting or angioplasty

6. Angiographic evidence of coronary artery compression that would result from
transcatheter pulmonic valve implantation (TPVI)

7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.

8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed
within the 30 day follow-up from the TPVI procedure.

9. History of or current intravenous drug use

10. Major or progressive non-cardiac disease resulting in a life expectancy of less than
one year

11. Known hypersensitivity to aspirin or heparin and cannot be treated with other
antiplatelet and/or antithrombotic medications

12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be
adequately premedicated

13. Participating in another investigational drug or device study that has not reached its
primary endpoint.

14. Female who is lactating or pregnant

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/7/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Donald Hagler, M.D.	Open for enrollment	Contact information: Structural Heart Disease Research Coordinators (507) 255-6133

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Donald Hagler, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35 mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1 year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40 mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n = 58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32 years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35 mm Hg). At 30 days, there were no major adjudicated adverse clinical events. At 1 year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderate PR, and 2.1% (1 of 48) mean RVOT gradient >40 mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1 year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677. Read More on PubMed

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