PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve (PII NR3/ViV)
|
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: NCT03225001 |
|
Recruitment Status :
Completed
First Posted : July 21, 2017
Results First Posted : January 9, 2018
Last Update Posted : March 9, 2021
|
Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
Resource links provided by the National Library of Medicine
| 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 :
- 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 :
- Number of Participants With Mortality From Any Cause [ Time Frame: 30 Days ]Cardiovascular cause is also included
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.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- 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.
- Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
Exclusion Criteria:
- Bioprosthetic valve labeled external diameter < 21mm.
- Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
- Infectious endocarditis within 6 months.
- 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
Locations
Show 47 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
| 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):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Keywords provided by Edwards Lifesciences:
|
SAPIEN XT Partner II cardiovascular disease heart disease aortic disease |
SAVR TAVR failing surgical valve failing valve failing bioprosthetic valve |
Additional relevant MeSH terms:
|
Cardiomyopathies Aortic Valve Stenosis Cardiomyopathy, Hypertrophic Heart Diseases Cardiovascular Diseases |
Aortic Valve Disease Heart Valve Diseases Ventricular Outflow Obstruction Aortic Stenosis, Subvalvular |