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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03225001 |
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Date of registration:
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17/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve |
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Date of first enrolment:
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June 11, 2012 |
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Target sample size:
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197 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03225001 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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John Webb, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Paul's Hospital, Vancouver, British columbia, Canada |
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Name:
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Michael Mack, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor Heart Hospital, Plano, TX |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Stenosis
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Cardiomyopathy, Hypertrophic
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Intervention(s)
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Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
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Primary Outcome(s)
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Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
[Time Frame: 30-day]
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Secondary Outcome(s)
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Number of Participants With Mortality From Any Cause
[Time Frame: 30 Days]
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Secondary ID(s)
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2010-12 NR3/ViV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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