PARTNERII B: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
Sponsor
Edwards Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02184442
Collaborator
American College of Cardiology (Other)
560
53
2
74.7
10.6
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
560 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
Actual Study Start Date
:
Mar 9, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
May 30, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAVR - SAPIEN XT TAVR (transaortic valve replacement) with SAPIEN XT |
Device: TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
|
| Active Comparator: TAVR - SAPIEN TAVR (transaortic valve replacement) with SAPIEN is the control arm |
Device: TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization [1 Year]
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Secondary Outcome Measures
- NYHA Classification - Change From Baseline [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 [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 [1 Year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
-
Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
-
The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
-
The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
-
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.
-
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
-
Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
-
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)
-
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.
-
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.
-
Active bacterial endocarditis within 6 months (180 days) of procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Heart Hospital/Clinic | Little Rock | Arkansas | United States | 72211 |
| 2 | Scripps Green Hospital | La Jolla | California | United States | 92037 |
| 3 | Scripps Memorial Hospital | La Jolla | California | United States | 92037 |
| 4 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 5 | Mercy General Hospital | Sacramento | California | United States | 95816 |
| 6 | Stanford University Medical Center | Stanford | California | United States | 94305 |
| 7 | University of Colorado Hospital | Denver | Colorado | United States | 80045 |
| 8 | Washington Hospital Center (WHC) | Washington | District of Columbia | United States | 20010 |
| 9 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 10 | University of Florida, Gainesville | Gainesville | Florida | United States | 32610 |
| 11 | University of Miami | Miami | Florida | United States | 33136 |
| 12 | Emory University Hospital | Atlanta | Georgia | United States | 30308 |
| 13 | Northwestern Hospital | Chicago | Illinois | United States | 60611 |
| 14 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 15 | Prairie Education and Research Cooperative | Springfield | Illinois | United States | 62701 |
| 16 | Indiana University Health-Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
| 17 | The University of Iowa | Iowa City | Iowa | United States | 52242 |
| 18 | University of Louisville - Jewish Hospital | Louisville | Kentucky | United States | 40202 |
| 19 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 20 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 21 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 22 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 23 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 24 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 25 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
| 26 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 27 | Saint Luke's Hospital of Kansas City Mid America | Kansas City | Missouri | United States | 64111 |
| 28 | Washington University - Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 29 | Nebraska Heart Institute | Lincoln | Nebraska | United States | 68526 |
| 30 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 31 | Newark Beth Israel | Newark | New Jersey | United States | 07112 |
| 32 | North Shore University Hospital, NY | Manhasset | New York | United States | 11030 |
| 33 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 34 | Cornell University | New York | New York | United States | 10021 |
| 35 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 36 | Medical University of South Carolina Charleston | Charleston | North Carolina | United States | 29425 |
| 37 | East Carolina Heart Institute at East Carolina University | Greenville | North Carolina | United States | 27834 |
| 38 | The Christ Hospital, Cincinnati | Cincinnati | Ohio | United States | 45219 |
| 39 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 40 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73135 |
| 41 | University of Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19104 |
| 42 | York Hospital | York | Pennsylvania | United States | 17403 |
| 43 | Baptist Memorial Hospital | Memphis | Tennessee | United States | 38120 |
| 44 | Austin Heart, PLLC | Austin | Texas | United States | 78756 |
| 45 | The Heart Hospital Baylor Plano | Dallas | Texas | United States | 75093 |
| 46 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 47 | The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center | Houston | Texas | United States | 77030 |
| 48 | University of Texas Health Science Center at San Antonio (UTHSCSA) | San Antonio | Texas | United States | 78229-3900 |
| 49 | Intermountain Medical Center | Murray | Utah | United States | 84157 |
| 50 | University of Virginia | Charlottesville | Virginia | United States | 22904 |
| 51 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 52 | University of Washington | Seattle | Washington | United States | 98195 |
| 53 | University of Wisconsin - Madison | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Edwards Lifesciences
- American College of Cardiology
Investigators
- Principal Investigator: Martin B Leon, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02184442
Other Study ID Numbers:
- 2010-12-PIIB
First Posted:
Jul 9, 2014
Last Update Posted:
Sep 25, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Edwards Lifesciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were screened and enrolled at 53 sites in the US and Canada |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TAVR - SAPIEN XT | TAVR - SAPIEN |
|---|---|---|
| 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 | 220 | 200 |
| NOT COMPLETED | 64 | 76 |
Baseline Characteristics
| Arm/Group Title | TAVR - SAPIEN XT | TAVR - SAPIEN | Total |
|---|---|---|---|
| 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 Participants | 284 | 276 | 560 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
84.0
(8.65)
|
84.6
(8.61)
|
84.3
(8.63)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
143
50.4%
|
134
48.6%
|
277
49.5%
|
| Male |
141
49.6%
|
142
51.4%
|
283
50.5%
|
| STS Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
10.3
(5.38)
|
11.0
(5.71)
|
10.6
(5.55)
|
| NYHA Class III/IV (Count of Participants) | |||
| Count of Participants [Participants] |
275
96.8%
|
265
96%
|
540
96.4%
|
| Coronary Artery Disease (Count of Participants) | |||
| Count of Participants [Participants] |
186
65.5%
|
186
67.4%
|
372
66.4%
|
| Frailty (Count of Participants) | |||
| Count of Participants [Participants] |
168
59.2%
|
166
60.1%
|
334
59.6%
|
Outcome Measures
| Title | Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization |
|---|---|
| Description | All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year |
| Time Frame | 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TAVR - SAPIEN XT | TAVR - SAPIEN |
|---|---|---|
| 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 |
| Measure Participants | 284 | 276 |
| Number [participants] |
105
37%
|
102
37%
|
| Title | NYHA Classification - Change From Baseline |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 204 | 192 |
| Mean (Standard Deviation) [Units on a scale] |
-1.8
(0.92)
|
-1.7
(0.91)
|
| Title | Total Aortic Regurgitation - Change From Baseline |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that all the valve-implant population do not have echo data. |
| Arm/Group Title | TAVR - SAPIEN XT | TAVR - SAPIEN |
|---|---|---|
| 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 |
| Measure Participants | 172 | 155 |
| Mean (Standard Deviation) [Grade] |
0.2
(1.38)
|
0.1
(1.23)
|
| Title | Effective Orifice Area - Change From Baseline |
|---|---|
| Description | |
| Time Frame | 1 Year |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 163 | 149 |
| Mean (Standard Deviation) [cm^2] |
0.9
(0.41)
|
0.9
(0.38)
|
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/282 (3.5%) | 12/271 (4.4%) | ||
Serious Adverse Events |
||||
| TAVR - SAPIEN XT | TAVR - SAPIEN | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 196/280 (70%) | 180/263 (68.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 12/280 (4.3%) | 13 | 14/263 (5.3%) | 16 |
| Thrombocytopenia | 0/280 (0%) | 0 | 5/263 (1.9%) | 5 |
| Cardiac disorders | ||||
| Angina | 12/280 (4.3%) | 14 | 0/263 (0%) | 0 |
| Arrhythmia | 33/280 (11.8%) | 37 | 30/263 (11.4%) | 31 |
| Cardiac arrest | 10/280 (3.6%) | 10 | 17/263 (6.5%) | 19 |
| Cardiac Tamponade/Pericardial Effusion | 4/280 (1.4%) | 4 | 2/263 (0.8%) | 2 |
| Cardiogenic Shock | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Endocarditis | 2/280 (0.7%) | 2 | 1/263 (0.4%) | 1 |
| Heart Failure / CHF / Low output Failure | 46/280 (16.4%) | 64 | 39/263 (14.8%) | 58 |
| Mitral Valve Injury or Insufficiency | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Non Structural Dysfunction | 6/280 (2.1%) | 6 | 6/263 (2.3%) | 6 |
| Stenosis | 2/280 (0.7%) | 2 | 2/263 (0.8%) | 2 |
| Ventricular rupture (Apical rupture) | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Gastro Intestinal Event | 11/280 (3.9%) | 11 | 10/263 (3.8%) | 12 |
| Gastro Intestinal Event Nonhemorrhagic | 6/280 (2.1%) | 7 | 2/263 (0.8%) | 2 |
| General disorders | ||||
| Coronary Flow Obstruction/Transvalvular flow disturbance | 2/280 (0.7%) | 2 | 1/263 (0.4%) | 1 |
| Device Embolization | 1/280 (0.4%) | 1 | 1/263 (0.4%) | 1 |
| Device Migration | 3/280 (1.1%) | 3 | 1/263 (0.4%) | 1 |
| Edema | 1/280 (0.4%) | 1 | 2/263 (0.8%) | 2 |
| Exercise intolerance or weakness | 1/280 (0.4%) | 1 | 1/263 (0.4%) | 1 |
| Multi Organ Failure | 3/280 (1.1%) | 3 | 1/263 (0.4%) | 1 |
| Other | 45/280 (16.1%) | 56 | 42/263 (16%) | 52 |
| Pain | 5/280 (1.8%) | 5 | 7/263 (2.7%) | 9 |
| Structural Dysfunction | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Unknown cause of Death | 8/280 (2.9%) | 8 | 5/263 (1.9%) | 5 |
| Infections and infestations | ||||
| Access site infection | 5/280 (1.8%) | 7 | 6/263 (2.3%) | 6 |
| Bacteremia | 2/280 (0.7%) | 2 | 4/263 (1.5%) | 5 |
| Respiratory Infection | 22/280 (7.9%) | 25 | 17/263 (6.5%) | 18 |
| Sepsis | 14/280 (5%) | 15 | 10/263 (3.8%) | 11 |
| Urinary Tract Infection | 12/280 (4.3%) | 13 | 10/263 (3.8%) | 11 |
| Injury, poisoning and procedural complications | ||||
| Failure of percutaneous access site closure resulting in intervention | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Fall | 7/280 (2.5%) | 7 | 10/263 (3.8%) | 11 |
| Investigations | ||||
| Abnormal lab value | 11/280 (3.9%) | 13 | 7/263 (2.7%) | 8 |
| Musculoskeletal and connective tissue disorders | ||||
| Fracture | 9/280 (3.2%) | 12 | 9/263 (3.4%) | 10 |
| Hemiplegia (One side limb weakness) | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Cancer | 5/280 (1.8%) | 5 | 1/263 (0.4%) | 1 |
| Nervous system disorders | ||||
| Dysphasia | 1/280 (0.4%) | 1 | 1/263 (0.4%) | 1 |
| Encephalopathy | 2/280 (0.7%) | 2 | 1/263 (0.4%) | 1 |
| Hemiparesis (One sided body weakness) | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Hemiplegia (One side limb weakness) | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Hemorrhagic Stroke | 1/280 (0.4%) | 1 | 3/263 (1.1%) | 3 |
| Ischemic Stroke | 11/280 (3.9%) | 11 | 8/263 (3%) | 8 |
| Undetermined Stroke | 5/280 (1.8%) | 5 | 2/263 (0.8%) | 2 |
| Psychiatric disorders | ||||
| Change in level of consciousness | 2/280 (0.7%) | 2 | 1/263 (0.4%) | 1 |
| Cognitive Impairment | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Confusion | 3/280 (1.1%) | 3 | 5/263 (1.9%) | 5 |
| Delirium | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Dementia | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Depression | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Renal and urinary disorders | ||||
| Genito Urinary Event | 4/280 (1.4%) | 4 | 0/263 (0%) | 0 |
| Genito Urinary Event Nonhemorrhagic | 0/280 (0%) | 0 | 1/263 (0.4%) | 1 |
| Renal Insufficiency or Renal Failure | 16/280 (5.7%) | 18 | 13/263 (4.9%) | 16 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Aspiration | 3/280 (1.1%) | 3 | 1/263 (0.4%) | 1 |
| Dyspnea | 8/280 (2.9%) | 8 | 7/263 (2.7%) | 7 |
| Pneumothorax | 1/280 (0.4%) | 1 | 3/263 (1.1%) | 3 |
| Pulmonary Edema | 3/280 (1.1%) | 3 | 5/263 (1.9%) | 5 |
| Pulmonary Effusion | 4/280 (1.4%) | 5 | 8/263 (3%) | 8 |
| Respiratory Failure | 15/280 (5.4%) | 16 | 15/263 (5.7%) | 17 |
| Vascular disorders | ||||
| Aortic root rupture | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
| Dissection | 10/280 (3.6%) | 10 | 14/263 (5.3%) | 14 |
| Distal embolization from vascular source | 2/280 (0.7%) | 2 | 2/263 (0.8%) | 2 |
| Embolization including air/calcific valve material or Thrombus | 3/280 (1.1%) | 3 | 4/263 (1.5%) | 4 |
| Hematoma | 5/280 (1.8%) | 5 | 5/263 (1.9%) | 5 |
| Hemorrhage | 37/280 (13.2%) | 41 | 30/263 (11.4%) | 35 |
| Hypertension | 2/280 (0.7%) | 2 | 1/263 (0.4%) | 1 |
| Hypotension | 5/280 (1.8%) | 5 | 7/263 (2.7%) | 7 |
| Ischemia | 2/280 (0.7%) | 2 | 0/263 (0%) | 0 |
| Myocardial Infarction | 6/280 (2.1%) | 6 | 5/263 (1.9%) | 5 |
| Perforation | 2/280 (0.7%) | 2 | 9/263 (3.4%) | 9 |
| Pseudoaneurysm | 4/280 (1.4%) | 4 | 8/263 (3%) | 8 |
| Syncope | 7/280 (2.5%) | 7 | 8/263 (3%) | 8 |
| TIA | 1/280 (0.4%) | 1 | 4/263 (1.5%) | 4 |
| Thoracic aortic dissection | 1/280 (0.4%) | 1 | 0/263 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| TAVR - SAPIEN XT | TAVR - SAPIEN | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 211/280 (75.4%) | 195/263 (74.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia/Hemolytic Anemia | 35/280 (12.5%) | 45 | 36/263 (13.7%) | 39 |
| Thrombocytopenia | 16/280 (5.7%) | 17 | 18/263 (6.8%) | 18 |
| Cardiac disorders | ||||
| Arrhythmia/Conduction System Injury (Defect) | 46/280 (16.4%) | 52 | 41/263 (15.6%) | 51 |
| Ear and labyrinth disorders | ||||
| Edema | 11/280 (3.9%) | 11 | 18/263 (6.8%) | 19 |
| Gastrointestinal disorders | ||||
| Gastro Intestinal Event | 19/280 (6.8%) | 21 | 19/263 (7.2%) | 22 |
| General disorders | ||||
| Other | 79/280 (28.2%) | 105 | 87/263 (33.1%) | 145 |
| Injury, poisoning and procedural complications | ||||
| Fall | 12/280 (4.3%) | 14 | 19/263 (7.2%) | 21 |
| Non Structural Dysfunction | 13/280 (4.6%) | 14 | 15/263 (5.7%) | 16 |
| Investigations | ||||
| Abnormal Lab Value | 49/280 (17.5%) | 75 | 52/263 (19.8%) | 77 |
| Psychiatric disorders | ||||
| Confusion | 8/280 (2.9%) | 8 | 16/263 (6.1%) | 18 |
| Renal and urinary disorders | ||||
| Renal Insufficiency or Renal Failure | 22/280 (7.9%) | 23 | 14/263 (5.3%) | 16 |
| Urinary Tract Infection | 28/280 (10%) | 31 | 35/263 (13.3%) | 45 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary Effusion | 25/280 (8.9%) | 29 | 18/263 (6.8%) | 21 |
| Respiratory Infection | 14/280 (5%) | 17 | 14/263 (5.3%) | 14 |
| Vascular disorders | ||||
| Hemorrhage | 28/280 (10%) | 33 | 30/263 (11.4%) | 34 |
| Hypotension | 12/280 (4.3%) | 12 | 17/263 (6.5%) | 17 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Tenley Koepnick |
|---|---|
| Organization | Edwards Life Sciences |
| Phone | 949-250-6504 |
| Tenley_Koepnick@Edwards.com |
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02184442
Other Study ID Numbers:
- 2010-12-PIIB
First Posted:
Jul 9, 2014
Last Update Posted:
Sep 25, 2018
Last Verified:
Aug 1, 2018