PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A)
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|ClinicalTrials.gov Identifier: NCT01314313|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Severe Aortic Stenosis||Device: TAVR Implantation with SAPIEN XT Device: SAVR Implantation||Not Applicable|
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
To assure that patients with an STS score ≥ 4% have been selected.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2032 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients|
|Actual Study Start Date :||March 2011|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||November 2024|
Experimental: PIIA - SAPIEN XT
PIIA is operable group
Device: TAVR Implantation with SAPIEN XT
Operable Group with SAPIEN XT
Active Comparator: Control: SAVR
SAVR (surgical aortic valve replacement) is the control arm
Device: SAVR Implantation
- All-cause Death or Disabling Stroke to Two Years [ Time Frame: 2 Years ]All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
- Adjusted Days Alive and Out of Hospital (DAOH) to Two Years [ Time Frame: 2 years ]The number of days the patients are alive and out of the hospital.
- Total Aortic Regurgitation (AR) at 2 Years [ Time Frame: 2 years ]Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
- 6MWT Change From Baseline [ Time Frame: Baseline and 2 years ]Six Minute Walk Test change from baseline to 2 years
- NYHA Classification at 2 Years [ Time Frame: 2 years ]New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
- Effective Orifice Area (EOA) [ Time Frame: 2 years ]
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): NCT01314313
|Principal Investigator:||Martin B Leon, MD||Columbia University|
|Principal Investigator:||Craig Smith, MD||Columbia University|