Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 199 for:    Louisville AND placed

The PARTNER II Trial: S3iCAP (The PARTNER II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02687035
Recruitment Status : Active, not recruiting
First Posted : February 22, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: TAVR with SAPIEN S3 valve Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1822 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)
Actual Study Start Date : January 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAPIEN 3
Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system
Device: TAVR with SAPIEN S3 valve
Transcatheter aortic valve replacement
Other Names:
  • TAVR
  • TAVI
  • Transcatheter aortic valve replacement
  • SAPIEN




Primary Outcome Measures :
  1. Stroke [ Time Frame: 30 days ]
  2. Aortic valve reintervention [ Time Frame: 30 days ]
  3. Death [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Annular dissection [ Time Frame: 30 days ]
  2. Aortic dissection [ Time Frame: 30 days ]
  3. Major access site vascular complications [ Time Frame: 30 days ]
  4. Unplanned vascular surgery or intervention [ Time Frame: 30 days ]
  5. Retroperitoneal bleed [ Time Frame: 30 days ]
  6. GI bleed [ Time Frame: 30 days ]
  7. GU bleed [ Time Frame: 30 days ]
  8. Bleeding at access sites [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687035


  Show 56 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Layout table for investigator information
Principal Investigator: Susheel Kodali, MD University of Columbia
Principal Investigator: Vinod Thourani, MD Emory University

Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02687035     History of Changes
Other Study ID Numbers: 2010-12 - S3iCAP
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Edwards Lifesciences:
S3iCAP
SAPIEN 3
Transfemoral
Commander
Certitude
TAVR
TAVI
Aortic stenosis
THV
Transcatheter Heart Valve
TVT
TVTR

Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction