Trial · NCT01314313

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

NCT01314313, Not applicable, Completed, Edwards Lifesciences; results first posted 2018-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk. Trials, record NCT01314313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01314313

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
NCT number: NCT01314313
Status: Completed
Phases: Not applicable
Enrollment: 2,032 participants, actual
Lead sponsor: Edwards Lifesciences
Conditions: Symptomatic Severe Aortic Stenosis
Interventions: TAVR Implantation with SAPIEN XT, SAVR Implantation
First posted: 2011-03-14
Last updated: 2024-03-07
Results first posted: 2018-08-14

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	All-cause Death or Disabling Stroke to Two Years	2 Years	All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Secondary	Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	2 years	The number of days the patients are alive and out of the hospital.
Secondary	Total Aortic Regurgitation (AR) at 2 Years	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.
Secondary	6MWT Change From Baseline	Baseline and 2 years	Six Minute Walk Test change from baseline to 2 years
Secondary	NYHA Classification at 2 Years	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.
Secondary	Effective Orifice Area (EOA)	2 years

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	All-cause Death or Disabling Stroke to Two Years	2 Years	Participants include all patients who were randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	2 years	Intent to Treat Population: All randomized patients with the exception of Total Aortic Regurgitation and Effective Orifice Area which was analyzed with the Valve Implant Population: All randomized patients receiving the valve.	days	MEAN
SECONDARY	Total Aortic Regurgitation (AR) at 2 Years	2 years	All randomized patients who received the valve were analyzed. Note: Echos were not available for all the patients who made the follow-up visit.	Grade	MEAN
SECONDARY	6MWT Change From Baseline	Baseline and 2 years		meters	MEAN
SECONDARY	NYHA Classification at 2 Years	2 years		units on a scale	MEAN
SECONDARY	Effective Orifice Area (EOA)	2 years	Effective Orifice Area is listed for only the patients who had echo available at the follow-up visit.	cm^2	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
All-cause Death or Disabling Stroke to Two Years	PIIA: SAPIEN XT	192		Participants
All-cause Death or Disabling Stroke to Two Years	Control: SAVR	202		Participants
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	PIIA: SAPIEN XT	629.4	Standard Deviation 208.54	days
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	Control: SAVR	597.8	Standard Deviation 236.80	days
Total Aortic Regurgitation (AR) at 2 Years	PIIA: SAPIEN XT	1.2	Standard Deviation 1.0	Grade
Total Aortic Regurgitation (AR) at 2 Years	Control: SAVR	0.5	Standard Deviation 0.7	Grade
6MWT Change From Baseline	PIIA: SAPIEN XT	14.5	Standard Deviation 128.7	meters
6MWT Change From Baseline	Control: SAVR	NA	Standard Deviation NA	meters
NYHA Classification at 2 Years	PIIA: SAPIEN XT	1.5	Standard Deviation 0.7	units on a scale
NYHA Classification at 2 Years	Control: SAVR	1.4	Standard Deviation 0.6	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PIIA: SAPIEN XT	1,011
Overall Study	STARTED	Control: SAVR	1,021
Overall Study	As Treated	PIIA: SAPIEN XT	994
Overall Study	As Treated	Control: SAVR	944
Overall Study	Valve Implanted	PIIA: SAPIEN XT	974
Overall Study	Valve Implanted	Control: SAVR	936
Overall Study	COMPLETED	PIIA: SAPIEN XT	784
Overall Study	COMPLETED	Control: SAVR	710
Overall Study	NOT COMPLETED	PIIA: SAPIEN XT	227
Overall Study	NOT COMPLETED	Control: SAVR	311

Source ClinicalTrials.gov

Adverse events224

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abnormal lab value	Investigations	PIIA: SAPIEN XT - 2 Year	187	974	260
other	Abnormal lab value	Investigations	Control: SAVR - 2 Year	257	936	404
other	Anemia/Hemolytic anemia	Blood and lymphatic system disorders	PIIA: SAPIEN XT - 2 Year	168	974	192
other	Anemia/Hemolytic anemia	Blood and lymphatic system disorders	Control: SAVR - 2 Year	198	936	219
other	Arrhythmia/Conduction system injury (defect)	Cardiac disorders	PIIA: SAPIEN XT - 2 Year	284	974	338
other	Arrhythmia/Conduction system injury (defect)	Cardiac disorders	Control: SAVR - 2 Year	409	936	507
other	Bleeding - Hemorrhage	Vascular disorders	PIIA: SAPIEN XT - 2 Year	285	974	345
other	Bleeding - Hemorrhage	Vascular disorders	Control: SAVR - 2 Year	421	936	500
other	Edema	General disorders	PIIA: SAPIEN XT - 2 Year	39	974	40
other	Edema	General disorders	Control: SAVR - 2 Year	53	936	56

1 to 10 of 224Source ClinicalTrials.gov

See all 224 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PIIA: SAPIEN XT - 2 Year	166	1,011
Total, all-cause mortality	Control: SAVR - 2 Year	170	1,021
Total, other adverse events	PIIA: SAPIEN XT - 2 Year	838	974
Total, other adverse events	Control: SAVR - 2 Year	864	936
Total, serious adverse events	PIIA: SAPIEN XT - 2 Year	666	974
Total, serious adverse events	Control: SAVR - 2 Year	672	936

Source ClinicalTrials.gov

Papers25

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25855679	DERIVED	PubMed
26384204	DERIVED	PubMed
26718510	DERIVED	PubMed
27040324	DERIVED	PubMed
27190101	DERIVED	PubMed
27400898	DERIVED	PubMed
28427598	DERIVED	PubMed
28473128	DERIVED	PubMed
28658491	DERIVED	PubMed
28973091	DERIVED	PubMed

1 to 10 of 25

See all 25 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
PIIA: SAPIEN XT vs Control: SAVR: All-cause Death or Disabling Stroke to Two Years	Trial comparisons
PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: deaths from any cause	Trial comparisons
PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01314313

GET https://conductscience.org/api/trials/v1/NCT01314313/events?page=2

API reference For AI assistants