Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
Lead Sponsor: Rabin Medical Center
|Source||Rabin Medical Center|
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk. As cancer therapy improves, some AS patients suffering active malignancy (including advanced metastatic diseases) may be more endangered by their untreated valvular disease than their oncological disease. Among these patients, TAVI may be indicated before cancer related surgery or cardiotoxic anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. Individualized life expectancy assumptions should be evaluated by the heart team in the clinical decision-making process as an essential factor in weighing the risk-benefit ratio for oncologic patients undergoing TAVI. A multicenter, international TAVI in Oncology Patients with AS (TOP-AS) registry was designed to collect data on patients with an active malignancy and severe AS undergoing TAVI. The aim of the study is to evaluate the outcomes, benefits and risks of oncology patients undergoing TAVI, mainly the patients' survival and cause of death and also the interactions between the valvular and the oncologic conditions.
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.
|Start Date||January 1, 2017|
|Completion Date||March 1, 2019|
|Primary Completion Date||March 1, 2019|
|Study Type||Observational [Patient Registry]|
Intervention Type: Device
Intervention Name: Native aortic valve
Description: Native valve, with any transcatheter heart valve type
Intervention Type: Procedure
Intervention Name: Transcatheter aortic valve implantation (TAVI)
Description: Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.
Sampling Method: Probability Sample
Inclusion Criteria: - Patients with active malignancy (all types excluding non-melanoma skin Ca) - Severe aortic stenosis undergoing native valve TAVI (any transcatheter heart valve type). Exclusion Criteria: - TAVI for conditions other than severe AS. - Valve in valve TAVI patient. - Patients cured /in remission from cancer during the index TAVI.
- Patients with active malignancy (all types excluding non-melanoma skin Ca)
- Severe aortic stenosis undergoing native valve TAVI (any transcatheter heart valve type).
- TAVI for conditions other than severe AS.
- Valve in valve TAVI patient.
- Patients cured /in remission from cancer during the index TAVI.
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: Rabin Medical Center
Investigator Full Name: Uri Landes
Investigator Title: Principal Investigator
|Has Expanded Access||No|
Label: TAVI Patients with active cancer
Description: Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
Label: TAVI patients without cancer
Description: Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
|Study Design Info||
Observational Model: Cohort
Time Perspective: Other