Trial Search Results

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Intervention(s):

  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Phase:

Phase 3

Eligibility


Inclusion Criteria

All Candidates for this study (Cohorts A, B and S3) must meet the following criteria:

   1. 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.

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

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

   4. 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.

   5. 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.

Once eligibility in accordance to the above criteria is established, 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 Eligibility Criteria Specific to Cohort A:

Inclusion Criteria:

   1. STS ≥ 4

   2. Heart team (including examining cardiac surgeon) agrees on eligibility including
   assessment that TAVR or AVR is appropriate

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

   4. Study patient agrees to undergo surgical aortic valve replacement (AVR) - if
   randomized to control treatment.

Additional Eligibility Criteria Specific to Cohort B

Inclusion Criteria:

   1. 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%.

   2. The heart team agrees the patient is likely to benefit from valve replacement.

Additional Eligibility Criteria Specific to the PIIS3 High Risk Cohort/ NR7

Inclusion Criteria:

   1. STS > 8

   2. For inoperable patients: Same as #1 for additional eligibility criteria specific to
   Cohort B

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

Additional Eligibility Criteria Specific to the PIIS3 Intermediate Risk Cohort/ NR8

Inclusion Criteria:

   1. Assessment of Intermediate surgical risk define as STS 4-8% or Heart Team assessment
   of intermediate risk factors.

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

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

Exclusion Criteria

Exclusion Criteria for Cohort A, Cohort B and the S3 Cohorts (including NR7 and NR8):

   1. 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)].

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

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

   4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).

   5. 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.

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

   7. Patient with planned concomitant surgical or transcatheter ablation for Atrial
   Fibrillation.

   8. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Pit <
   50,000 cell/mL).

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

10. Severe ventricular dysfunction with LVEF < 20%.

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

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

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

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

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

16. Estimated life expectancy < 24 months (730 days) due carcinomas, chronic liver
   disease, chronic renal disease or chronic end stage pulmonary disease.

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

18. 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.

19. It is known that the patient is currently enrolled in The PARTNER I Trial.

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

Exclusion Criteria Specific to Cohort A:

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

   2. Complex coronary artery disease:

      - Unprotected left main coronary artery

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

   3. Native aortic annulus size < 18 mm or> 27 mm as measured by echocardiogram.

   4. Patient refuses aortic valve replacement surgery.

Exclusion Criteria Specific to Cohort B and the S3 Cohorts (including NR7 and NR8):

   1. Heart team assessment of inoperability (including examining cardiac surgeon). PIIS3
   intermediate risk cohort and NR8 only.

   2. Untreated clinically significant coronary artery disease requiring revascularization.
   Cohort B,PIIS3 high risk cohort and NR7 only.

   3. Complex coronary artery disease (S3i) and NR8 only):

      1. Unprotected left main coronary artery

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

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

   5. Need for emergency surgery for any reason.

   6. Native aortic annulus size < 18 mm or > 25 mm for Cohort B and <16mm or >28mm for the
   S3 Cohort (including NR7, and NR8 and CAP), as measured by echocardiogram.

   7. 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).

   8. Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F
   for Cohort B and 14F or 16F for the S3 Cohorts (including NR7/NR8) introducer sheath
   such as severe obstructive calcification. Severe tortuosity or minimum average vessel
   size less than 7 mm (5.5 mm S3 Cohorts and NR7/NR) (Transfemoral).

Specific Criteria for Registry 1 (NR1) and Registry 4 (NR4)

Inclusion: Same criteria as Cohort B Including non-femoral access. Exclusion:

Same criteria as Cohort B except exclusionary criteria #15 only excludes patients with
renal insufficiency (creatinine >3.0 mg/dL).

Specific Criteria for Registry 2 (NR2)

Inclusion: Same criteria as Cohort B Including non-femoral access Exclusion: Same criteria
as Cohort B, except for exclusion 22 which is modified for NR2 as follows:

• Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F
introducer sheath such as severe obstructive calcification, severe tortuosity or minimum
average vessel size less than 6 mm and exclusionary criteria #15 only excludes patients
with renal insufficiency (creatinine> 3.0 mg/dL).

Specific Criteria for Registry 3 (NR3)

Inclusion:

   1. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic
   position.

   2. NYHA class > II.

   3. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.

Exclusion:

   1. Bioprosthetic valve labeled external diameter < 21mm.

   2. Surgical or transcatheter valve in another position on the same side of the heart
   (mitral and tricuspid rings are not an exclusion).

   3. Hemodynamic instability defined as requiring inotropic, pressor, or mechanical
   support.

   4. Infectious endocarditis within 6 months.

   5. Bacteremia within 1 month.

   6. Intra-cardiac thrombus or vegetation.

   7. 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 ≥ twice normal in the presence
   of MB elevation and/or troponin level elevation (WHO definition)].

   8. Percutaneous coronary intervention or implantation of a permanent pacemaker within 7
   days of the index procedure.

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

10. Hypertrophic cardiomyopathy with obstruction (HOCM).

11. Severe ventricular dysfunction with LVEF < 20%.

12. Active upper GI bleeding within 3 months (90 days) prior to procedure requiring
   transfusion.

13. Inability to be anticoagulated for the study procedure.

14. Stroke or transient ischemic attack within 6 months (180 days).

15. Insufficiency (creatinine > 3.0 mg/dL).

16. Estimated life expectancy < 24 months.

17. 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.

18. The patient requires emergency surgery for any reason.

19. Xenograft or THV in another position.

20. Index valve has moderate or severe paravalvular regurgitation.

21. Index valve is unstable or rocking.

22. Extensive, severe non-revascularized coronary disease.

23. Increased risk of coronary obstruction by prosthetic leaflets (non-stented or
   internally stented valve which might extend above a coronary ostium).

24. Increased risk of embolization (non-stented and non-calcified valve). Specific
   Criteria for Registry 5 (NR5) and Registry 6 (NR6) Inclusion: Same criteria as Cohort
   B including non-femoral access Exclusion: Same criteria as Cohort B except "Native
   aortic annulus size <18mm or >27mm as measured by echocardiogram and exclusionary
   criteria #15 only excludes patients with renal insufficiency (creatinine> 3.0 mg/dL).

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Martina Kelly Speight
6507252687
Recruiting