All-cause Mortality
Primary
· 30 days
All of the deaths that occurred in this population regardless of the cause.
| Group | Value | 95% CI |
|---|---|---|
| Patients With SAPIEN XT THV | 4 |
Last reviewed · How we verify
NCT03314857
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
Completed
NA
Results posted
Last updated 5 September 2023
What this trial tests
NA trial testing SAPIEN XT THV with the NovaFlex+ delivery system in Aortic Stenosis in 67 participants. Completed in 15 June 2023.
Timeline
18 September 2017
Primary endpoint
6 July 2018
6 July 2018
15 June 2023
Quick facts
| Lead sponsor | Edwards Lifesciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 18 September 2017 |
| Primary completion | 6 July 2018 |
| Estimated completion | 15 June 2023 |
| Sites | 3 locations across China |
Drugs / interventions tested
- SAPIEN XT THV with the NovaFlex+ delivery system
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
- Symptomatic Aortic Stenosis — all drugs for Symptomatic Aortic Stenosis →
- Aortic Regurgitation — all drugs for Aortic Regurgitation →
Sponsor
Edwards Lifesciences — full company profile →
Who can join
60 and older, any sex, with Aortic Stenosis or Symptomatic Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cardiovascular Mortality
Secondary
· 30 days
All of the deaths that occurred in this population due to a cardiovascular issue.
| Group | Value | 95% CI |
|---|---|---|
| Patients With SAPIEN XT THV | 4 |
Number of Participates With a Stroke
Secondary
· 30 days
Total number of participates with a stroke.
| Group | Value | 95% CI |
|---|---|---|
| Patients With SAPIEN XT THV | 0 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 30-days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients With SAPIEN XT THV
Serious: 16/61 (26%)
Deaths: 4/61
Serious adverse events (18 terms)
| Reaction | System | Patients With SAPIEN XT THV |
|---|---|---|
| Device dislocation | Product Issues | — |
| Acute coronary syndrome | Cardiac disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Atrioventricular block complete | Cardiac disorders | — |
| Bundle branch block left | Cardiac disorders | — |
| Cardiac failure acute | Cardiac disorders | — |
| Cardio-respiratory arrest | Cardiac disorders | — |
| Myocardial rupture | Cardiac disorders | — |
| Sinus arrest | Cardiac disorders | — |
| Device failure | Product Issues | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — |
| Depressed level of consciousness | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| Device embolisation | General disorders | — |
| Lung infection | Infections and infestations | — |
| Vascular access site complication | Injury, poisoning and procedural complications | — |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | — |
| Iliac artery perforation | Vascular disorders | — |
Other adverse events (11 terms — click to expand)
| Reaction | System | Patients With SAPIEN XT THV |
|---|---|---|
| Troponin T increased | Investigations | — |
| Bundle branch block left | Cardiac disorders | — |
| Post procedural fever | Injury, poisoning and procedural complications | — |
| Procedural haemorrhage | Injury, poisoning and procedural complications | — |
| Constipation | Gastrointestinal disorders | — |
| Atrioventricular block first degree | Cardiac disorders | — |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | — |
| Pyrexia | General disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Post procedural constipation | Injury, poisoning and procedural complications | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Device dislocation, Acute coronary syndrome, Atrial fibrillation, Atrioventricular block complete, Bundle branch block left, Cardiac failure acute, Cardio-respiratory arrest, Myocardial rupture.
Data from ClinicalTrials.gov NCT03314857 adverse events section.
Sponsor's own description
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03314857
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Edwards Lifesciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03314857 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Edwards Lifesciences
- Last refreshed: 5 September 2023
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/NCT03314857.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing