PARTNER II Trial: S3iCAP

Aortic Stenosis Clinical Trial

— PII S3i CAP  

Official title:

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687035
• Other study ID #: 2010-12 S3iCAP
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Description:

This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1822
• Est. completion date: December 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted.

2. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.

3. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of < 0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.

4. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).

5. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.

6. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.

7. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).

8. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

9. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Exclusion Criteria:

1. Heart team assessment of inoperability (including examining cardiac surgeon).

2. Evidence of an acute myocardial infarction = 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB = twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].

3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

4. Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation >3+).

5. Pre-existing mechanical or bioprosthetic valve in any position.

6. Complex coronary artery disease:

1. Unprotected left main coronary artery

2. Syntax score > 32 (in the absence of prior revascularization)

7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.

8. Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).

9. Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.

10. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL).

11. Hypertrophic cardiomyopathy with or without obstruction (HOCM).

12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.

13. Need for emergency surgery for any reason.

14. Severe ventricular dysfunction with LVEF < 20%.

15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

16. Active upper GI bleeding within 3 months (90 days) prior to procedure.

17. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.

18. Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram.

19. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.

20. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.

21. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease.

22. Expectation that patient will not improve despite treatment of aortic stenosis.

23. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)

24. Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral).

25. Currently participating in an investigational drug or an-other device study. Note:

Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

26. Active bacterial endocarditis within 6 months (180 days) of procedure.

27. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.

28. Inability to tolerate anticoagulation/antiplatelet therapy.

29. For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26 mm system and < 6.0 mm for the 29 mm system.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• SAPIEN S3 valve
Transcatheter aortic valve replacement

Locations

Country	Name	City	State
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia
United States	University of Michigan Hospital and Health Systems	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Austin Heart, PLLC	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina Charleston	Charleston	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	University of Colorado Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	NorthShore University HealthSystem Research Institute	Evanston	Illinois
United States	University of Florida	Gainesville	Florida
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University Health-Methodist Hospital	Indianapolis	Indiana
United States	St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Saint Luke's Hospital of Kansas City Mid America	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Louisville Jewish Hospital	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Winthrop-University Hospital	Mineola	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Cornell University	New York	New York
United States	Northshore Long Island Jewish Health System	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Providence Heart & Vascular Institute	Portland	Oregon
United States	Mayo Clinic-Saint Marys Hospital	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Washington University/ Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Washington Hospital Center DC	Washington	District of Columbia
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Number of deaths	30 days
Primary	Death	Number of deaths	1 year
Primary	Stroke	Number of participants with stroke	30 days
Primary	Stroke	Number of participants with stroke	1 year
Primary	Aortic Valve Reintervention	Number of participants with aortic valve reintervention	30 days
Primary	Aortic Valve Reintervention	Number of participants with aortic valve reintervention	1 year
Secondary	Annular Dissection	Number of participants with annular dissection	30 days
Secondary	Aortic Dissection	Number of participants with aortic dissection	30 days
Secondary	Major Access Vascular Site Complication	Number of participants with major vascular complications	30 days
Secondary	Unplanned Vascular Surgery or Intervention	Number of participants with unplanned vascular surgery or intervention	30 days
Secondary	Retroperitoneal Bleeds	Number of participants with retroperitoneal bleed	30 days
Secondary	Gastrointestinal Bleed	Number of participants with gastrointestinal bleeding	30 days
Secondary	Genitourinary Bleed	Number of participants with genitourinary bleeding	30 days
Secondary	Bleeding at Access Site	Number of participants with bleeding at the access site	30 days