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NCT Number: NCT03181997

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

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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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Malignancy Neoplasms Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Rabin Medical Center,

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Native aortic valve

Device

Native valve, with any transcatheter heart valve type

Transcatheter Aortic Valve Implantation (TAVI)

Procedure

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

Primary outcomes

  1. Patients survival

    Time frame: 2 years

    Patients survival in days

Secondary outcomes

  1. New York Heart Association Functional Classification (NYHA FC)

    Time frame: 2 years

    Provides information regarding patients functional status on scale of 1-4.

  2. Cause of death

    Time frame: 2 years

    Whether the cause of death is cardiovascular or non-cardiovascular.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis

Acronym: TOP-AS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2017
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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