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

NCT03181997 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis
  • Malignancy

Interventions

DEVICE

Native aortic valve

Native valve, with any transcatheter heart valve type

PROCEDURE

Transcatheter aortic valve implantation (TAVI)

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Ran Kornowski, Prof,MD · Chairman, Dept. of Cardiology, Rabin Medical Center, Israel

  • Ran Kornowski, Prof,MD · Chairman, Dept. of Cardiology, Rabin Medical Center, Israel

  • Uri Landes, MD · Dept. of Cardiology, Rabin Medical Center, Israel

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181997 on ClinicalTrials.gov