The Partner II Trial: A Study of the Placement of Aortic Transcatheter Valves

Overview

About this study

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

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

  • Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria within 60 days of the date of the procedure.
    • 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 
  • Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  • The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  • 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.
  • 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.
  • Patients are assessed for operability (in-operable, high risk, intermediate risk). All candidates must meet the above criteria in order to be stratified into Cohort A, Cohort B or S3.

Additional Criteria Specific to Cohort A

  • STS ≥ 4
  • Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR or AVR is appropriate
  • Heart team agrees on treatment strategy for concomitant coronary disease (if present)
  • Study patient agrees to undergo surgical aortic valve replacement (AVR) - if randomized to control treatment.

Additional Criteria Specific to Cohort B

  • The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity is ≥ 50%.
  • The heart team agrees the patient is likely to benefit from valve replacement.

Additional Criteria Specific to the PIIS3 High Risk Cohort

  • STS > 8
  • For inoperable patients: Same as #1 for additional eligibility criteria specific to Cohort B
  • Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT or MRI).

Additional  Criteria Specific to the PIIS3 Intermediate Risk Cohort/ NR8

  • Assessment of Intermediate surgical risk define as STS 4-8% 
  • Heart Team assessment of intermediate risk factors.
  • Aortic valve annulus area range (273 mm2-680 mm2) per 3D imaging (echo, CT, or MRI).
  • Heart team agrees on treatment strategy for concomitant coronary disease (if present).

Additional Criteria S3i CAP Patients Only

  • Patients must be covered by Medicare. This will enable TVTR to link to the CMS database for long term follow-up through 5 years.

 

Exclusion Criteria

  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment,defined as
    • Q wave MI
    • 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)
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  • Preexisting mechanical or bioprosthetic valve in any position (except NR3).
  • 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 (S3 Cohort only) is not excluded.
  • Any patient with a balloon valvuloplasty (BAV) within 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
  • Patient with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
  • Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Pit < 50,000 cell/mL).
  • Hypertrophic cardiomyopathy with or without obstruction (HOCM).
  • Severe ventricular dysfunction with LVEF < 20%.
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  • Active upper GI bleeding within 3 months (90 days) prior to procedure.
  • A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  • Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
  • Renal insufficiency (creatinine> 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
  • Estimated life expectancy < 24 months (730 days) due carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
  • Expectation that patient will not improve despite treatment of aortic stenosis.
  • Currently participating in an investigational drug or another device study
    • Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • It is known that the patient is currently enrolled in The PARTNER I Trial (except S3i CAP).
  • Active bacterial endocarditis within 6 months (180 days) of procedure.

Exclusion Criteria Specific to Cohort A

  • Heart team assessment of inoperability (including examining cardiac surgeon).
  • Complex coronary artery disease
    • Unprotected left main coronary artery
    • Syntax score> 32 (in the absence of prior revascularization)
  • Native aortic annulus size < 18 mm or> 27 mm as measured by echocardiogram.
  • Patient refuses aortic valve replacement surgery.

Exclusion Criteria Specific to Cohort B and the S3 Cohorts

  • Heart team assessment of inoperability (including examining cardiac surgeon) PIIS3 intermediate risk cohort (including CAP) and NR8 only.
  • Untreated clinically significant coronary artery disease requiring revascularization. Cohort B, PIIS3 high risk cohort .
  • Complex coronary artery disease (S3i (including CAP) and NR8 only)
    1. Unprotected left main coronary artery
    2. Syntax score > 32 (in the absence of prior revascularization)
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
  • Need for emergency surgery for any reason.
  • Native aortic annulus size < 18 mm or > 25 mm for Cohort B and <16mm or >28mm for the S3 Cohort (including NR8 and CAP), as measured by echocardiogram.
  • 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).
  • Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F for Cohort B and 14F or 16F for the S3 Cohorts (NR8) introducer sheath such as severe obstructive calcification. Severe tortuosity or minimum average vessel size less than 7 mm (5.5 mm S3 Cohorts)

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

David Holmes, M.D.

Closed for enrollment

Contact information:

Ramona Johnson R.N.

(507) 293-1703

Johnson.Ramona@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20151959

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