Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TAVI Patients with active cancer

Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.

Native aortic valve

Intervention Type DEVICE

Native valve, with any transcatheter heart valve type

Transcatheter aortic valve implantation (TAVI)

Intervention Type PROCEDURE

Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.

TAVI patients without cancer

Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.

Native aortic valve

Intervention Type DEVICE

Native valve, with any transcatheter heart valve type

Transcatheter aortic valve implantation (TAVI)

Intervention Type PROCEDURE

Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.

Interventions

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Native aortic valve

Native valve, with any transcatheter heart valve type

Intervention Type DEVICE

Transcatheter aortic valve implantation (TAVI)

Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.

Intervention Type PROCEDURE

Eligibility Criteria

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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).