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

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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:
Collaborator:
American College of Cardiology
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Severe
Symptomatic
Calcific Aortic Stenosis
Interventions Device: TAVR Implantation with SAPIEN XT
Device: TAVR Implantation with SAPIEN
Enrollment 560
Recruitment Details Subjects were screened and enrolled at 53 sites in the US and Canada
Pre-assignment Details  
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Period Title: Overall Study
Started 284 276
As-Treated 282 271
Valve-Implant 280 263
Completed [1] 220 200
Not Completed 64 76
Reason Not Completed
Death             61             65
Withdrawal by Subject             3             11
[1]
One-year Follow-up
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN Total
Hide Arm/Group Description

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Total of all reporting groups
Overall Number of Baseline Participants 284 276 560
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 284 participants 276 participants 560 participants
84.0  (8.65) 84.6  (8.61) 84.3  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 276 participants 560 participants
Female
143
  50.4%
134
  48.6%
277
  49.5%
Male
141
  49.6%
142
  51.4%
283
  50.5%
STS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 284 participants 276 participants 560 participants
10.3  (5.38) 11.0  (5.71) 10.6  (5.55)
[1]
Measure Description: The Society of Thoracic Surgeons (STS) Score measures patient risk of mortality and morbidity at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
NYHA Class III/IV   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 276 participants 560 participants
275
  96.8%
265
  96.0%
540
  96.4%
[1]
Measure Description: 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.
Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 276 participants 560 participants
186
  65.5%
186
  67.4%
372
  66.4%
Frailty  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 276 participants 560 participants
168
  59.2%
166
  60.1%
334
  59.6%
1.Primary Outcome
Title Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Hide Description All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description:

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Overall Number of Participants Analyzed 284 276
Measure Type: Number
Unit of Measure: participants
105 102
2.Secondary Outcome
Title NYHA Classification - Change From Baseline
Hide Description 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.
Time Frame Baseline and 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that all the patients were not available for a NYHA functional assessment
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description:

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Overall Number of Participants Analyzed 204 192
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.8  (0.92) -1.7  (0.91)
3.Secondary Outcome
Title Total Aortic Regurgitation - Change From Baseline
Hide Description

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.

Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that all the valve-implant population do not have echo data.
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description:

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Overall Number of Participants Analyzed 172 155
Mean (Standard Deviation)
Unit of Measure: Grade
0.2  (1.38) 0.1  (1.23)
4.Secondary Outcome
Title Effective Orifice Area - Change From Baseline
Hide Description [Not Specified]
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Valve Implant Population; Please note that echo data was not available for all patients.
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description:

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

Overall Number of Participants Analyzed 163 149
Mean (Standard Deviation)
Unit of Measure: cm^2
0.9  (0.41) 0.9  (0.38)
Time Frame Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock.
Adverse Event Reporting Description

All adverse events are site reported

Only Valve-Implanted patients are reported for all adverse events (except for mortality).

 
Arm/Group Title TAVR - SAPIEN XT TAVR - SAPIEN
Hide Arm/Group Description

TAVR (transaortic valve replacement) with SAPIEN XT

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

TAVR (transaortic valve replacement) with SAPIEN is the control arm

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

All-Cause Mortality
TAVR - SAPIEN XT TAVR - SAPIEN
Affected / at Risk (%) Affected / at Risk (%)
Total   10/282 (3.55%)      12/271 (4.43%)    
Hide Serious Adverse Events
TAVR - SAPIEN XT TAVR - SAPIEN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   196/280 (70.00%)      180/263 (68.44%)    
Blood and lymphatic system disorders     
Anemia  1  12/280 (4.29%)  13 14/263 (5.32%)  16
Thrombocytopenia  1  0/280 (0.00%)  0 5/263 (1.90%)  5
Cardiac disorders     
Angina  1  12/280 (4.29%)  14 0/263 (0.00%)  0
Arrhythmia  1  33/280 (11.79%)  37 30/263 (11.41%)  31
Cardiac arrest  1  10/280 (3.57%)  10 17/263 (6.46%)  19
Cardiac Tamponade/Pericardial Effusion  1  4/280 (1.43%)  4 2/263 (0.76%)  2
Cardiogenic Shock  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Endocarditis  1  2/280 (0.71%)  2 1/263 (0.38%)  1
Heart Failure / CHF / Low output Failure  1  46/280 (16.43%)  64 39/263 (14.83%)  58
Mitral Valve Injury or Insufficiency  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Non Structural Dysfunction  1  6/280 (2.14%)  6 6/263 (2.28%)  6
Stenosis  1  2/280 (0.71%)  2 2/263 (0.76%)  2
Ventricular rupture (Apical rupture)  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Gastrointestinal disorders     
Gastro Intestinal Event  1  11/280 (3.93%)  11 10/263 (3.80%)  12
Gastro Intestinal Event Nonhemorrhagic  1  6/280 (2.14%)  7 2/263 (0.76%)  2
General disorders     
Coronary Flow Obstruction/Transvalvular flow disturbance  1  2/280 (0.71%)  2 1/263 (0.38%)  1
Device Embolization  1  1/280 (0.36%)  1 1/263 (0.38%)  1
Device Migration  1  3/280 (1.07%)  3 1/263 (0.38%)  1
Edema  1  1/280 (0.36%)  1 2/263 (0.76%)  2
Exercise intolerance or weakness  1  1/280 (0.36%)  1 1/263 (0.38%)  1
Multi Organ Failure  1  3/280 (1.07%)  3 1/263 (0.38%)  1
Other  1  45/280 (16.07%)  56 42/263 (15.97%)  52
Pain  1  5/280 (1.79%)  5 7/263 (2.66%)  9
Structural Dysfunction  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Unknown cause of Death  1  8/280 (2.86%)  8 5/263 (1.90%)  5
Infections and infestations     
Access site infection  1  5/280 (1.79%)  7 6/263 (2.28%)  6
Bacteremia  1  2/280 (0.71%)  2 4/263 (1.52%)  5
Respiratory Infection  1  22/280 (7.86%)  25 17/263 (6.46%)  18
Sepsis  1  14/280 (5.00%)  15 10/263 (3.80%)  11
Urinary Tract Infection  1  12/280 (4.29%)  13 10/263 (3.80%)  11
Injury, poisoning and procedural complications     
Failure of percutaneous access site closure resulting in intervention  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Fall  1  7/280 (2.50%)  7 10/263 (3.80%)  11
Investigations     
Abnormal lab value  1  11/280 (3.93%)  13 7/263 (2.66%)  8
Musculoskeletal and connective tissue disorders     
Fracture  1  9/280 (3.21%)  12 9/263 (3.42%)  10
Hemiplegia (One side limb weakness)  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  5/280 (1.79%)  5 1/263 (0.38%)  1
Nervous system disorders     
Dysphasia  1  1/280 (0.36%)  1 1/263 (0.38%)  1
Encephalopathy  1  2/280 (0.71%)  2 1/263 (0.38%)  1
Hemiparesis (One sided body weakness)  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Hemiplegia (One side limb weakness)  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Hemorrhagic Stroke  1  1/280 (0.36%)  1 3/263 (1.14%)  3
Ischemic Stroke  1  11/280 (3.93%)  11 8/263 (3.04%)  8
Undetermined Stroke  1  5/280 (1.79%)  5 2/263 (0.76%)  2
Psychiatric disorders     
Change in level of consciousness  1  2/280 (0.71%)  2 1/263 (0.38%)  1
Cognitive Impairment  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Confusion  1  3/280 (1.07%)  3 5/263 (1.90%)  5
Delirium  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Dementia  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Depression  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Renal and urinary disorders     
Genito Urinary Event  1  4/280 (1.43%)  4 0/263 (0.00%)  0
Genito Urinary Event Nonhemorrhagic  1  0/280 (0.00%)  0 1/263 (0.38%)  1
Renal Insufficiency or Renal Failure  1  16/280 (5.71%)  18 13/263 (4.94%)  16
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  3/280 (1.07%)  3 1/263 (0.38%)  1
Dyspnea  1  8/280 (2.86%)  8 7/263 (2.66%)  7
Pneumothorax  1  1/280 (0.36%)  1 3/263 (1.14%)  3
Pulmonary Edema  1  3/280 (1.07%)  3 5/263 (1.90%)  5
Pulmonary Effusion  1  4/280 (1.43%)  5 8/263 (3.04%)  8
Respiratory Failure  1  15/280 (5.36%)  16 15/263 (5.70%)  17
Vascular disorders     
Aortic root rupture  1  1/280 (0.36%)  1 0/263 (0.00%)  0
Dissection  1  10/280 (3.57%)  10 14/263 (5.32%)  14
Distal embolization from vascular source  1  2/280 (0.71%)  2 2/263 (0.76%)  2
Embolization including air/calcific valve material or Thrombus  1  3/280 (1.07%)  3 4/263 (1.52%)  4
Hematoma  1  5/280 (1.79%)  5 5/263 (1.90%)  5
Hemorrhage  1  37/280 (13.21%)  41 30/263 (11.41%)  35
Hypertension  1  2/280 (0.71%)  2 1/263 (0.38%)  1
Hypotension  1  5/280 (1.79%)  5 7/263 (2.66%)  7
Ischemia  1  2/280 (0.71%)  2 0/263 (0.00%)  0
Myocardial Infarction  1  6/280 (2.14%)  6 5/263 (1.90%)  5
Perforation  1  2/280 (0.71%)  2 9/263 (3.42%)  9
Pseudoaneurysm  1  4/280 (1.43%)  4 8/263 (3.04%)  8
Syncope  1  7/280 (2.50%)  7 8/263 (3.04%)  8
TIA  1  1/280 (0.36%)  1 4/263 (1.52%)  4
Thoracic aortic dissection  1  1/280 (0.36%)  1 0/263 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAVR - SAPIEN XT TAVR - SAPIEN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   211/280 (75.36%)      195/263 (74.14%)    
Blood and lymphatic system disorders     
Anemia/Hemolytic Anemia  1  35/280 (12.50%)  45 36/263 (13.69%)  39
Thrombocytopenia  1  16/280 (5.71%)  17 18/263 (6.84%)  18
Cardiac disorders     
Arrhythmia/Conduction System Injury (Defect)  1  46/280 (16.43%)  52 41/263 (15.59%)  51
Ear and labyrinth disorders     
Edema  1  11/280 (3.93%)  11 18/263 (6.84%)  19
Gastrointestinal disorders     
Gastro Intestinal Event  1  19/280 (6.79%)  21 19/263 (7.22%)  22
General disorders     
Other  1  79/280 (28.21%)  105 87/263 (33.08%)  145
Injury, poisoning and procedural complications     
Fall  1  12/280 (4.29%)  14 19/263 (7.22%)  21
Non Structural Dysfunction  1  13/280 (4.64%)  14 15/263 (5.70%)  16
Investigations     
Abnormal Lab Value  1  49/280 (17.50%)  75 52/263 (19.77%)  77
Psychiatric disorders     
Confusion  1  8/280 (2.86%)  8 16/263 (6.08%)  18
Renal and urinary disorders     
Renal Insufficiency or Renal Failure  1  22/280 (7.86%)  23 14/263 (5.32%)  16
Urinary Tract Infection  1  28/280 (10.00%)  31 35/263 (13.31%)  45
Respiratory, thoracic and mediastinal disorders     
Pulmonary Effusion  1  25/280 (8.93%)  29 18/263 (6.84%)  21
Respiratory Infection  1  14/280 (5.00%)  17 14/263 (5.32%)  14
Vascular disorders     
Hemorrhage  1  28/280 (10.00%)  33 30/263 (11.41%)  34
Hypotension  1  12/280 (4.29%)  12 17/263 (6.46%)  17
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tenley Koepnick
Organization: Edwards Life Sciences
Phone: 949-250-6504
EMail: Tenley_Koepnick@Edwards.com
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02184442    
Other Study ID Numbers: 2010-12-PIIB
First Submitted: January 17, 2014
First Posted: July 9, 2014
Results First Submitted: December 7, 2017
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018