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NCT01819181 · ClinicalTrials.gov registry record
Women's INternational Transcatheter Aortic Valve Implantation Registry
A clinical trial of Symptomatic Aortic Stenosis, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 1,019
- Enrollment target
- 10
- Study locations
NCT01819181: Completed study of Symptomatic Aortic Stenosis, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01819181 is a study of Symptomatic Aortic Stenosis that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 1,019 participants. The trial reports 10 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819181, a study of Symptomatic Aortic Stenosis, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 1,019 participants
- Enrollment target
- 10
- Study locations
Study Summary
The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.
Primary Outcome
The primary study endpoint is the VARC 2 early safety endpoint at 30-days (all-cause mortality, all stroke \[disabling and non disabling\], life-threatening bleeding, stage 2 or 3 acute kidney injury \[AKI\], coronary artery obstruction requiring intervention, major vascular complications, repeat procedure for valve-related dysfunction).
Conditions Studied
Study Locations (10)
Other
- Hôpital Privé Parly 2 - Le Chesnay
- Azienda Ospedaliero - Ferrarotto Alessi - Catania
- Instituto Clinico Humanitas - Milan
- San Raffaele Hospital - Milan
- Department cardiovascular Sciences Policlinico Umberto I - Rome
- Radboud University Nijmegen Medical Center - Nijmegen
- Erasmus Medical Center Rotterdam - Rotterdam
- Hospital Universitario Miguel Servet - Zaragoza
- Imperial College - London
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,019 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-04-26 |
What the finished NCT01819181 record still lists
NCT01819181 is an observational study that tracks outcomes without assigning an intervention. Its 1,019 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Symptomatic Aortic Stenosis appearing as the primary indexed condition, and to 0 interventions.
NCT01819181 lists 10 locations in 2 states (Other, New York).
Frequently Asked Questions
What is clinical trial NCT01819181 about?
NCT01819181 is a clinical study titled "Women's INternational Transcatheter Aortic Valve Implantation Registry". The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.
What is the current status of trial NCT01819181?
This trial is currently completed. The enrollment target is 1,019 participants. The study started on 2013-03. Estimated completion is 2018-04-26.
What conditions does trial NCT01819181 study?
This clinical trial studies the following conditions: Symptomatic Aortic Stenosis.
Who is sponsoring clinical trial NCT01819181?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01819181 being conducted?
This trial has 10 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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