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NCT03181997: TOP-AS

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

Completed Last updated 28 March 2019
What this trial tests

trial testing Native aortic valve in Aortic Valve Stenosis in 168 participants. Completed in 1 March 2019.

Timeline
1 January 2017
Primary endpoint
1 March 2019
1 March 2019

Quick facts

Lead sponsorRabin Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment168
Start date1 January 2017
Primary completion1 March 2019
Estimated completion1 March 2019
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

Eligibility, any sex, with Aortic Valve Stenosis or Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis.
    Landes U, Iakobishvili Z, Vronsky D, Zusman O, et al · · 2019 · cited 61× · PMID 30621982 · DOI 10.1016/j.jcin.2018.10.026

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Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

Other Rabin Medical Center trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03181997.

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