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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

Tracking Information
First Submitted Date June 6, 2017
First Posted Date June 9, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2017)
Patients survival [ Time Frame: 2 years ]
Patients survival in days
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03181997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 8, 2017)
  • New York Heart Association Functional Classification (NYHA FC) [ Time Frame: 2 years ]
    Provides information regarding patients functional status on scale of 1-4.
  • Cause of death [ Time Frame: 2 years ]
    Whether the cause of death is cardiovascular or non-cardiovascular.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will be selected from several international transcatheter aortic valve implantation centers.
Condition
  • Aortic Valve Stenosis
  • Malignancy
Intervention
  • 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.
Study Groups/Cohorts
  • TAVI Patients with active cancer
    Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
    Interventions:
    • Device: Native aortic valve
    • Procedure: Transcatheter aortic valve implantation (TAVI)
  • TAVI patients without cancer
    Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
    Interventions:
    • Device: Native aortic valve
    • Procedure: Transcatheter aortic valve implantation (TAVI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2017)
168
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03181997
Other Study ID Numbers 0136-17-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Uri Landes, Rabin Medical Center
Study Sponsor Rabin Medical Center
Collaborators Not Provided
Investigators
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
PRS Account Rabin Medical Center
Verification Date March 2019