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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
NA trial testing TAVR Implantation with SAPIEN XT in Severe in 560 participants. Completed in 30 May 2017.
| Lead sponsor | Edwards Lifesciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 560 |
| Start date | 9 March 2011 |
| Primary completion | 1 May 2013 |
| Estimated completion | 30 May 2017 |
| Sites | 53 locations across United States |
Edwards Lifesciences — full company profile →
19 and older, any sex, with Severe or Symptomatic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
| Group | Value | 95% CI |
|---|---|---|
| TAVR - SAPIEN XT | 105 | |
| TAVR - SAPIEN | 102 |
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.
| Group | Value | 95% CI |
|---|---|---|
| TAVR - SAPIEN XT | -1.8 | ± 0.92 |
| TAVR - SAPIEN | -1.7 | ± 0.91 |
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.
| Group | Value | 95% CI |
|---|---|---|
| TAVR - SAPIEN XT | 0.2 | ± 1.38 |
| TAVR - SAPIEN | 0.1 | ± 1.23 |
| Group | Value | 95% CI |
|---|---|---|
| TAVR - SAPIEN XT | 0.9 | ± 0.41 |
| TAVR - SAPIEN | 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | TAVR - SAPIEN XT | TAVR - SAPIEN |
|---|---|---|---|
| Heart Failure / CHF / Low output Failure | Cardiac disorders | — | — |
| Other | General disorders | — | — |
| Hemorrhage | Vascular disorders | — | — |
| Arrhythmia | Cardiac disorders | — | — |
| Respiratory Infection | Infections and infestations | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Renal Insufficiency or Renal Failure | Renal and urinary disorders | — | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Dissection | Vascular disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Angina | Cardiac disorders | — | — |
| Urinary Tract Infection | Infections and infestations | — | — |
| Abnormal lab value | Investigations | — | — |
| Gastro Intestinal Event | Gastrointestinal disorders | — | — |
| Ischemic Stroke | Nervous system disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Perforation | Vascular disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pseudoaneurysm | Vascular disorders | — | — |
| Pulmonary Effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Syncope | Vascular disorders | — | — |
| Unknown cause of Death | General disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Reaction | System | TAVR - SAPIEN XT | TAVR - SAPIEN |
|---|---|---|---|
| Other | General disorders | — | — |
| Abnormal Lab Value | Investigations | — | — |
| Arrhythmia/Conduction System Injury (Defect) | Cardiac disorders | — | — |
| Anemia/Hemolytic Anemia | Blood and lymphatic system disorders | — | — |
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Hemorrhage | Vascular disorders | — | — |
| Pulmonary Effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal Insufficiency or Renal Failure | Renal and urinary disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Gastro Intestinal Event | Gastrointestinal disorders | — | — |
| Edema | Ear and labyrinth disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Non Structural Dysfunction | Injury, poisoning and procedural complications | — | — |
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Heart Failure / CHF / Low output Failure, Other, Hemorrhage, Arrhythmia, Respiratory Infection, Cardiac arrest, Renal Insufficiency or Renal Failure, Respiratory Failure.
Data from ClinicalTrials.gov NCT02184442 adverse events section.
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.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02184442.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing