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THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial (PARTNER)

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: NCT00530894
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : May 11, 2017
Last Update Posted : September 13, 2017
Sponsor:
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
Condition Critical Aortic Stenosis
Interventions Device: Edwards SAPIEN Transcatheter Heart Valve
Device: Surgical Valve Replacement
Other: medical management and/or balloon aortic valvuloplasty
Enrollment 1057
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description Edwards SAPIEN Transcatheter Heart Valve Surgical Aortic Valve Replacement Edwards SAPIEN Transcatheter Heart Valve Medical management and/or balloon aortic valvuloplasty
Period Title: Overall Study
Started 348 351 179 179
Completed 260 236 124 85
Not Completed 88 115 55 94
Reason Not Completed
Death             84             89             55             89
Lost to Follow-up             1             3             0             0
Withdrawal by Subject             1             23             0             5
Alive and censored prior to 1 year             2             0             0             0
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable TAVR Inoperable: Medical Therapy Total
Hide Arm/Group Description Edwards SAPIEN Transcatheter Heart Valve Surgical Valve Replacement Edwards SAPIEN Transcatheter Heart Valve Medical management and/or balloon aortic valvuloplasty Total of all reporting groups
Overall Number of Baseline Participants 348 349 179 179 1055
Hide Baseline Analysis Population Description
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials, therefore the pooled mean and standard deviations do not provide meaningful data and were not reported.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
High Risk 83.61  (6.83) 84.52  (6.37) NA [1]   (NA) NA [1]   (NA) 84.11  (6.61)
Inoperable NA [1]   (NA) NA [1]   (NA) 83.12  (8.60) 83.18  (8.29) 83.18  (8.43)
[1]
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
Female
147
  42.2%
151
  43.3%
97
  54.2%
95
  53.1%
490
  46.4%
Male
201
  57.8%
198
  56.7%
82
  45.8%
84
  46.9%
565
  53.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
Asian 2 0 5 0 7
Black/African American 11 8 4 9 32
White 324 328 165 162 979
Hispanic 9 9 5 8 31
Other 2 4 0 0 6
NYHA Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
High Risk Class II 20 21 NA [2]  NA [2]  41
Operable Class II NA [2]  NA [2]  14 11 25
High Risk Class III or IV 328 328 NA [2]  NA [2]  656
Inoperable Class III or IV NA [2]  NA [2]  165 168 333
[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.
[2]
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
High Risk KCCQ Overall 39.6  (21.8) 44.5  (21.8) NA [2]   (NA) NA [2]   (NA) 41.88  (21.93)
Inoperable KCCQ Overall NA [2]   (NA) NA [2]   (NA) 36.19  (20.52) 34.44  (20.14) 35.35  (20.32)
High Risk SF-12 Physical 29.6  (7.6) 30.9  (8.2) NA [2]   (NA) NA [2]   (NA) 30.2  (7.9)
Inoperable SF-12 Physical NA [2]   (NA) NA [2]   (NA) 28.23  (7.73) 27.70  (6.89) 28.0  (7.23)
High Risk SF-12 Mental 46.9  (11.5) 47.6  (10.7) NA [2]   (NA) NA [2]   (NA) 47.2  (11.1)
Inoperable SF-12 Mental NA [2]   (NA) NA [2]   (NA) 44.45  (12.16) 45.23  (11.03) 44.84  (11.5)
[1]
Measure Description: The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), EuroQOL, SF-12. The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
[2]
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
STS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 348 participants 349 participants 179 participants 179 participants 1055 participants
High Risk 11.8  (3.3) 11.7  (3.5) NA [2]   (NA) NA [2]   (NA) 11.75  (3.40)
Inoperable NA [2]   (NA) NA [2]   (NA) 11.2  (5.8) 11.9  (4.8) 11.51  (5.34)
[1]
Measure Description: The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
[2]
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
1.Primary Outcome
Title Death
Hide Description Death from any cause.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Surgical Aortic Valve Replacement
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 348 351 179 179
Measure Type: Number
Unit of Measure: participants
84 89 55 89
2.Primary Outcome
Title Composite of Death and Recurrence Hospitalization.
Hide Description Death from any cause or repeat hospitalization after intervention.
Time Frame duration of study
Hide Outcome Measure Data
Hide Analysis Population Description
Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.
Arm/Group Title Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 179 179
Measure Type: Number
Unit of Measure: participants
76 126
3.Secondary Outcome
Title Functional Change of NYHA
Hide Description NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Time Frame Baseline to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Surgical Aortic Valve Replacement
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 334 314 172 167
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on scale
2.50
(2.35 to 2.65)
2.60
(2.45 to 2.76)
2.88
(2.70 to 3.07)
3.92
(3.73 to 4.11)
4.Secondary Outcome
Title Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Hide Description Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Surgical Aortic Valve Replacement
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 348 351 179 179
Measure Type: Number
Unit of Measure: participants
93 97 61 93
5.Secondary Outcome
Title Total Hospital Days From the Index Procedure
Hide Description Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Surgical Aortic Valve Replacement
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 348 351 179 179
Mean (Standard Deviation)
Unit of Measure: Days
17.42  (19.05) 20.14  (23.85) 25.24  (21.11) 17.04  (33.46)
6.Secondary Outcome
Title Change in Quality of Life (QOL) From Baseline to 1 Year
Hide Description

The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.

KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.

SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.

Time Frame Baseline and 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description:
Edwards SAPIEN Transcatheter Heart Valve
Surgical Aortic Valve Replacement
Edwards SAPIEN Transcatheter Heart Valve
Medical management and/or balloon aortic valvuloplasty
Overall Number of Participants Analyzed 348 351 179 179
Mean (Standard Deviation)
Unit of Measure: Units on a scale
KCCQ Overall 70.0  (22.4) 71.1  (23.0) 69.41  (25.37) 46.98  (24.59)
SF-12 Physical 36.3  (11.0) 36.9  (10.4) 34.85  (11.13) 29.68  (6.47)
SF-12 Mental 52.0  (10.1) 52.9  (9.7) 53.31  (10.00) 46.59  (11.68)
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Hide Arm/Group Description Edwards SAPIEN Transcatheter Heart Valve Surgical Aortic Valve Replacement Edwards SAPIEN Transcatheter Heart Valve Medical management and/or balloon aortic valvuloplasty
All-Cause Mortality
High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   228/348 (65.52%)      238/351 (67.81%)      134/179 (74.86%)      151/179 (84.36%)    
Blood and lymphatic system disorders         
Hemolysis  2  0/348 (0.00%)  0 1/351 (0.28%)  1 0/179 (0.00%)  0 0/179 (0.00%)  0
Cardiac disorders         
CHF  2  50/348 (14.37%)  73 51/351 (14.53%)  64 24/179 (13.41%)  32 78/179 (43.58%)  102
Arrhythmia  2  32/348 (9.20%)  34 38/351 (10.83%)  44 22/179 (12.29%)  24 24/179 (13.41%)  32
Conduction defects  2  11/348 (3.16%)  11 12/351 (3.42%)  12 5/179 (2.79%)  5 4/179 (2.23%)  4
Syncope  2  6/348 (1.72%)  6 5/351 (1.42%)  5 3/179 (1.68%)  4 6/179 (3.35%)  8
Aortic insufficiency without paravalvular leak  2  4/348 (1.15%)  4 0/351 (0.00%)  0 1/179 (0.56%)  1 0/179 (0.00%)  0
Pericardial effusion  2  2/348 (0.57%)  2 1/351 (0.28%)  2 0/179 (0.00%)  0 0/179 (0.00%)  0
Valve stenosis  2  1/348 (0.29%)  1 3/351 (0.85%)  3 1/179 (0.56%)  1 33/179 (18.44%)  42
Mitral insufficiency  2  1/348 (0.29%)  1 0/351 (0.00%)  0 0/179 (0.00%)  0 0/179 (0.00%)  0
Gastrointestinal disorders         
Gastro-Intestinal Event  2  22/348 (6.32%)  24 16/351 (4.56%)  18 9/179 (5.03%)  9 7/179 (3.91%)  10
General disorders         
Other  1  91/348 (26.15%)  127 86/351 (24.50%)  129 60/179 (33.52%)  98 68/179 (37.99%)  105
Device embolization  2  6/348 (1.72%)  6 0/351 (0.00%)  0 0/179 (0.00%)  0 0/179 (0.00%)  0
Fever  2  4/348 (1.15%)  4 0/351 (0.00%)  0 2/179 (1.12%)  3 1/179 (0.56%)  1
Device migration  2  1/348 (0.29%)  1 0/351 (0.00%)  0 0/179 (0.00%)  0 0/179 (0.00%)  0
Perivalvular leak  2  1/348 (0.29%)  1 0/351 (0.00%)  0 2/179 (1.12%)  2 0/179 (0.00%)  0
Infections and infestations         
Infection (including Endocarditis)  2  70/348 (20.11%)  96 59/351 (16.81%)  74 35/179 (19.55%)  53 30/179 (16.76%)  38
Injury, poisoning and procedural complications         
Perforation or damage to myocardium  2  3/348 (0.86%)  3 1/351 (0.28%)  1 1/179 (0.56%)  1 0/179 (0.00%)  0
Access site nerve injury  2  0/348 (0.00%)  0 0/351 (0.00%)  0 1/179 (0.56%)  1 0/179 (0.00%)  0
Investigations         
Abnormal Lab Values  2  16/348 (4.60%)  19 15/351 (4.27%)  17 12/179 (6.70%)  17 11/179 (6.15%)  17
Metabolism and nutrition disorders         
Electrolyte Imbalance  2  1/348 (0.29%)  1 0/351 (0.00%)  0 0/179 (0.00%)  0 0/179 (0.00%)  0
Nervous system disorders         
Neurological event (including TIA stroke and psychomotor deficit)  4  33/348 (9.48%)  33 24/351 (6.84%)  28 24/179 (13.41%)  28 7/179 (3.91%)  8
Renal and urinary disorders         
Renal failure  2  20/348 (5.75%)  21 26/351 (7.41%)  29 11/179 (6.15%)  12 12/179 (6.70%)  12
Renal insufficiency  2  8/348 (2.30%)  8 8/351 (2.28%)  8 2/179 (1.12%)  2 3/179 (1.68%)  3
Respiratory, thoracic and mediastinal disorders         
Respiratory Event  2  46/348 (13.22%)  66 61/351 (17.38%)  76 25/179 (13.97%)  28 21/179 (11.73%)  23
Pleural Effusion  2  15/348 (4.31%)  16 14/351 (3.99%)  15 3/179 (1.68%)  3 5/179 (2.79%)  7
Vascular disorders         
Bleeding event  3  32/348 (9.20%)  33 38/351 (10.83%)  42 23/179 (12.85%)  26 13/179 (7.26%)  14
Hemorrhagic/Vascular event  2  21/348 (6.03%)  22 20/351 (5.70%)  20 23/179 (12.85%)  24 9/179 (5.03%)  9
Hypotension  2  11/348 (3.16%)  11 14/351 (3.99%)  14 9/179 (5.03%)  9 4/179 (2.23%)  4
Angina  2  7/348 (2.01%)  9 4/351 (1.14%)  5 2/179 (1.12%)  4 4/179 (2.23%)  5
Ischemia  2  4/348 (1.15%)  4 2/351 (0.57%)  2 2/179 (1.12%)  2 2/179 (1.12%)  2
MI  2  4/348 (1.15%)  4 4/351 (1.14%)  4 5/179 (2.79%)  5 6/179 (3.35%)  6
Hematoma  2  3/348 (0.86%)  3 2/351 (0.57%)  2 2/179 (1.12%)  2 1/179 (0.56%)  1
Thromboembolism  2  4/348 (1.15%)  4 3/351 (0.85%)  4 3/179 (1.68%)  3 0/179 (0.00%)  0
Hypertension  2  0/348 (0.00%)  0 1/351 (0.28%)  1 3/179 (1.68%)  4 0/179 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 1+E21+E16:E40
2
Term from vocabulary, MedDRA 10.0
3
Term from vocabulary, STS/FDA
4
Term from vocabulary, STS/AATS
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Risk: TAVR High Risk: SAVR Inoperable: TAVR Inoperable: Medical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   230/348 (66.09%)      217/351 (61.82%)      140/179 (78.21%)      103/179 (57.54%)    
Cardiac disorders         
Arrhythmia  1  43/348 (12.36%)  49 78/351 (22.22%)  88 26/179 (14.53%)  30 16/179 (8.94%)  18
CHF  1  18/348 (5.17%)  18 7/351 (1.99%)  7 8/179 (4.47%)  8 15/179 (8.38%)  17
Valve stenosis  1  0/348 (0.00%)  0 0/351 (0.00%)  0 1/179 (0.56%)  1 11/179 (6.15%)  11
Gastrointestinal disorders         
Gastro-Intestinal Event  1  22/348 (6.32%)  29 21/351 (5.98%)  22 13/179 (7.26%)  18 7/179 (3.91%)  9
General disorders         
Other  1  133/348 (38.22%)  242 124/351 (35.33%)  219 87/179 (48.60%)  204 44/179 (24.58%)  80
Infections and infestations         
Infection (including Endocarditis)  1  60/348 (17.24%)  80 58/351 (16.52%)  69 44/179 (24.58%)  57 34/179 (18.99%)  52
Investigations         
Abnormal Lab Values  1  84/348 (24.14%)  128 84/351 (23.93%)  136 51/179 (28.49%)  86 28/179 (15.64%)  46
Nervous system disorders         
Neurological event (including TIA stroke and psychomotor deficit) * 1  0/348 (0.00%)  0 0/351 (0.00%)  0 10/179 (5.59%)  11 10/179 (5.59%)  10
Renal and urinary disorders         
Renal insufficiency  1  0/348 (0.00%)  0 0/351 (0.00%)  0 10/179 (5.59%)  10 3/179 (1.68%)  3
Respiratory, thoracic and mediastinal disorders         
Respiratory Event  1  33/348 (9.48%)  38 32/351 (9.12%)  35 15/179 (8.38%)  18 10/179 (5.59%)  12
Pleural Effusion  1  24/348 (6.90%)  25 47/351 (13.39%)  52 15/179 (8.38%)  17 7/179 (3.91%)  7
Vascular disorders         
Bleeding event  1  25/348 (7.18%)  27 22/351 (6.27%)  25 16/179 (8.94%)  21 7/179 (3.91%)  7
Hemorrhagic/Vascular event  1  25/348 (7.18%)  26 7/351 (1.99%)  7 20/179 (11.17%)  25 3/179 (1.68%)  3
Hypotension  1  19/348 (5.46%)  19 16/351 (4.56%)  17 19/179 (10.61%)  22 8/179 (4.47%)  9
Hematoma  1  18/348 (5.17%)  18 2/351 (0.57%)  2 24/179 (13.41%)  28 8/179 (4.47%)  8
Hypertension  1  0/348 (0.00%)  0 0/351 (0.00%)  0 12/179 (6.70%)  12 1/179 (0.56%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.

Site cannot publish or present on overall study results not yet published. PI may publish his own clinical study data subject to EW review prior submission or presentation, but data analyses of site-specific results can occur only in intervals as specified in the CSA.

Publication of site-specific results cannot include claims of device safety and effectiveness and requires EW review.

Results Point of Contact
Name/Title: Tenley Koepnick
Organization: Edwards Lifesciences
Phone: 949-250-6504
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00530894     History of Changes
Other Study ID Numbers: 2006-06-US
First Submitted: September 14, 2007
First Posted: September 18, 2007
Results First Submitted: March 7, 2016
Results First Posted: May 11, 2017
Last Update Posted: September 13, 2017