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

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Brief Title

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

Official Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Patients survival

Secondary Outcome

 New York Heart Association Functional Classification (NYHA FC)

Condition

Aortic Valve Stenosis

Intervention

Native aortic valve

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

168

Start Date

January 1, 2017

Completion Date

March 1, 2019

Primary Completion Date

March 1, 2019

Eligibility 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

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ran Kornowski, Prof,MD, ,

Location Countries

Israel

Location Countries

Israel

Administrative Informations

NCT ID

NCT03181997

Organization ID

0136-17-RMC

Responsible Party

Principal Investigator

Study Sponsor

Rabin Medical Center

Study Sponsor

Ran Kornowski, Prof,MD, Study Chair, Chairman, Dept. of Cardiology, Rabin Medical Center, Israel

Verification Date

March 2019