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Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis (TOP-AS)

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ClinicalTrials.gov Identifier: NCT03181997
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Uri Landes, Rabin Medical Center

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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Malignancy Device: Native aortic valve Procedure: Transcatheter aortic valve implantation (TAVI)

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAVI Patients with active cancer
Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
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.

TAVI patients without cancer
Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
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.




Primary Outcome Measures :
  1. Patients survival [ Time Frame: 2 years ]
    Patients survival in days


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be selected from several international transcatheter aortic valve implantation centers.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181997


Locations
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Israel
Rabin Medical Center,
Petaẖ Tiqwa, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Study Chair: Ran Kornowski, Prof,MD Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
Study Director: Ran Kornowski, Prof,MD Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
Principal Investigator: Uri Landes, MD Dept. of Cardiology, Rabin Medical Center, Israel

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uri Landes, Principal Investigator, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03181997     History of Changes
Other Study ID Numbers: 0136-17-RMC
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Uri Landes, Rabin Medical Center:
Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Cancer
Malignancy
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Neoplasms
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction