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

Sponsors

Lead Sponsor: Rabin Medical Center

Source Rabin Medical Center
Brief Summary

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.

Detailed Description

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.

Overall Status Completed
Start Date January 1, 2017
Completion Date March 1, 2019
Primary Completion Date March 1, 2019
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Patients survival 2 years
Secondary Outcome
Measure Time Frame
New York Heart Association Functional Classification (NYHA FC) 2 years
Cause of death 2 years
Enrollment 168
Condition
Intervention

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.

Eligibility

Sampling Method: Probability Sample

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Rabin Medical Center,
Location Countries

Israel

Verification Date

March 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: Uri Landes

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

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.

Acronym TOP-AS
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Other

Source: ClinicalTrials.gov