Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis (TOP-AS)
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|ClinicalTrials.gov Identifier: NCT03181997|
Recruitment Status : Enrolling by invitation
First Posted : June 9, 2017
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis Malignancy||Device: Native aortic valve Procedure: Transcatheter aortic valve implantation (TAVI)|
The TAVI program was initiated in Rabin Medical Center in 2008 and the institutional review board approved the prospective collection of our TAVI Database (i.e. RECORD TAVI). During these years, several oncology patients were treated with TAVI. Also, in daily practice a few asymptomatic AS patients in whom TAVI was indicated before cancer related surgery / cardiotoxic anti-cancer therapy underwent TAVI.
This study will initiate a multicenter, international registry designed to collect data on TAVI in cancer patients in correspondence to medical records within each center. Data will be collected retrospectively for cases performed before registry initiation and prospectively thereafter. All inconsistencies regarding data collection will be resolved directly with local investigators and on-site data monitoring. Patients' inclusion approval is by a local ethics committee in each center.
Saving Data: Data will be recorded in Excel table; each center and patient will receive a unique code so the data file will be anonymous.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||168 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2019|
TAVI Patients with active cancer
Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
Device: Native aortic valve
Native valve, with any transcatheter heart valve type
Procedure: Transcatheter aortic valve implantation (TAVI)
Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.
- Patients survival [ Time Frame: 2 years ]Patients survival in days
- New York Heart Association Functional Classification (NYHA FC) [ Time Frame: 2 years ]Provides information regarding patients functional status on scale of 1-4.
- Cause of death [ Time Frame: 2 years ]Whether the cause of death is cardiovascular or non-cardiovascular.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181997
|Rabin Medical Center,|
|Petaẖ Tiqwa, Israel|
|Study Chair:||Ran Kornowski, Prof,MD||Chairman, Dept. of Cardiology, Rabin Medical Center, Israel|
|Study Director:||Ran Kornowski, Prof,MD||Chairman, Dept. of Cardiology, Rabin Medical Center, Israel|
|Principal Investigator:||Uri Landes, MD||Dept. of Cardiology, Rabin Medical Center, Israel|