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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve (PII NR3/ViV)

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ClinicalTrials.gov Identifier: NCT03225001
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : January 9, 2018
Last Update Posted : March 9, 2021
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Cardiomyopathy, Hypertrophic Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX Not Applicable

Detailed Description:
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
Actual Study Start Date : June 11, 2012
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : October 28, 2020

Arm Intervention/treatment
Experimental: Failing surgical valve
Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
Other Name: TAVI

Primary Outcome Measures :
  1. Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) [ Time Frame: 30-day ]
    The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak

Secondary Outcome Measures :
  1. Number of Participants With Mortality From Any Cause [ Time Frame: 30 Days ]
    Cardiovascular cause is also included

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion 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 was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
  4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
  6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.

Exclusion Criteria:

  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. Infectious endocarditis within 6 months.
  4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

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): NCT03225001

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Sponsors and Collaborators
Edwards Lifesciences
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Principal Investigator: John Webb, MD St. Paul's Hospital, Vancouver, British columbia, Canada
Principal Investigator: Michael Mack, MD Baylor Heart Hospital, Plano, TX
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03225001    
Other Study ID Numbers: 2010-12 NR3/ViV
First Posted: July 21, 2017    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: March 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
Partner II
cardiovascular disease
heart disease
aortic disease
failing surgical valve
failing valve
failing bioprosthetic valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction
Aortic Stenosis, Subvalvular