The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)

• ClinicalTrials.gov Identifier: NCT02184442
• Recruitment Status: Completed
• First Posted: July 9, 2014
• Results First Posted: August 14, 2018
• Last Update Posted: September 25, 2018
• Sponsor: Edwards Lifesciences
• Collaborator: American College of Cardiology
• Information provided by (Responsible Party): Edwards Lifesciences

Tracking Information

• First Submitted Date: January 17, 2014
• First Posted Date: July 9, 2014
• Results First Submitted Date: December 7, 2017
• Results First Posted Date: August 14, 2018
• Last Update Posted Date: September 25, 2018
• Actual Study Start Date: March 9, 2011
• Actual Primary Completion Date: May 1, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2018)

Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization [ Time Frame: 1 Year ]

All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

Original Primary Outcome Measures (submitted: July 8, 2014)

• The clinical event of stroke [ Time Frame: 30 days ]
• The clinical event of stroke [ Time Frame: 1 Year ]

Current Secondary Outcome Measures (submitted: July 17, 2018)

• NYHA Classification - Change From Baseline [ Time Frame: Baseline and 1 Year ]
  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.
• Total Aortic Regurgitation - Change From Baseline [ Time Frame: 1 Year ]
  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 one year was analyzed in the valve implant population.
• Effective Orifice Area - Change From Baseline [ Time Frame: 1 Year ]

Original Secondary Outcome Measures (submitted: July 8, 2014)

VARC composite safety -Major vascular complications -Stroke [ Time Frame: 30 days and 1 year ]

• VARC composite safety:
  • All cause mortality
  • Stroke
  • Life-threatening (or disabling) bleeding
  • Acute kidney injury - Stage 3 (including renal replacement therapy)
  • Peri-procedural MI
  • Repeat procedure for valve related dysfunction
• Major vascular complications
• Stroke

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
• Official Title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
• Brief Summary: The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Detailed Description

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Severe
• Symptomatic
• Calcific Aortic Stenosis

Intervention

• Device: TAVR Implantation with SAPIEN XT
  Inoperable operable patients requiring the transcatheter aortic heart valve replacement
• Device: TAVR Implantation with SAPIEN
  Inoperable operable patients requiring the transcatheter aortic heart valve replacement

Study Arms

• Experimental: TAVR - SAPIEN XT
  TAVR (transaortic valve replacement) with SAPIEN XT
  Intervention: Device: TAVR Implantation with SAPIEN XT
• Active Comparator: TAVR - SAPIEN
  TAVR (transaortic valve replacement) with SAPIEN is the control arm
  Intervention: Device: TAVR Implantation with SAPIEN

Publications *

• Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
• Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
• Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 17, 2018): 560
• Original Actual Enrollment (submitted: July 8, 2014): 5000
• Actual Study Completion Date: May 30, 2017
• Actual Primary Completion Date: May 1, 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
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. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

Exclusion Criteria

1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
2. 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)
3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
5. Active bacterial endocarditis within 6 months (180 days) of procedure.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02184442
• Other Study ID Numbers: 2010-12-PIIB
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Edwards Lifesciences
• Study Sponsor: Edwards Lifesciences
• Collaborators: American College of Cardiology

Investigators

• Principal Investigator: Martin B Leon, MD; Columbia University

• PRS Account: Edwards Lifesciences
• Verification Date: August 2018