NCT03181997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

June 6, 2017

Last Update Submit

March 26, 2019

Conditions

Aortic Valve StenosisMalignancy

Keywords

Aortic Valve StenosisTranscatheter Aortic Valve ImplantationCancerMalignancy

Outcome Measures

Primary Outcomes (1)

  • Patients survival

    Patients survival in days

    2 years

Secondary Outcomes (2)

  • New York Heart Association Functional Classification (NYHA FC)

    2 years

  • Cause of death

    2 years

Study Arms (2)

TAVI Patients with active cancer

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

Device: Native aortic valveProcedure: Transcatheter aortic valve implantation (TAVI)

TAVI patients without cancer

Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.

Device: Native aortic valveProcedure: Transcatheter aortic valve implantation (TAVI)

Interventions

Native aortic valveDEVICE

Native valve, with any transcatheter heart valve type

TAVI Patients with active cancerTAVI patients without cancer
Transcatheter aortic valve implantation (TAVI)PROCEDURE

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

TAVI Patients with active cancerTAVI patients without cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be selected from several international transcatheter aortic valve implantation centers.

You may qualify if:

  • Patients with active malignancy (all types excluding non-melanoma skin Ca)
  • Severe aortic stenosis undergoing native valve TAVI (any transcatheter heart valve type).

You may not qualify if:

  • TAVI for conditions other than severe AS.
  • Valve in valve TAVI patient.
  • Patients cured /in remission from cancer during the index TAVI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center,

Petah Tikva, Israel

Location

Related Publications (4)

  • Swain SM, Kim SB, Cortes J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013 May;14(6):461-71. doi: 10.1016/S1470-2045(13)70130-X. Epub 2013 Apr 18.

    PMID: 23602601BACKGROUND

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.

    PMID: 28315732BACKGROUND

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available.

    PMID: 24603191BACKGROUND

  • Landes U, Iakobishvili Z, Vronsky D, Zusman O, Barsheshet A, Jaffe R, Jubran A, Yoon SH, Makkar RR, Taramasso M, Russo M, Maisano F, Sinning JM, Shamekhi J, Biasco L, Pedrazzini G, Moccetti M, Latib A, Pagnesi M, Colombo A, Tamburino C, D' Arrigo P, Windecker S, Pilgrim T, Tchetche D, De Biase C, Guerrero M, Iftikhar O, Bosmans J, Bedzra E, Dvir D, Mylotte D, Sievert H, Watanabe Y, Sondergaard L, Dagnegard H, Codner P, Kodali S, Leon M, Kornowski R. Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis. JACC Cardiovasc Interv. 2019 Jan 14;12(1):78-86. doi: 10.1016/j.jcin.2018.10.026.

    PMID: 30621982DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisNeoplasms

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Ran Kornowski, Prof,MD

    Chairman, Dept. of Cardiology, Rabin Medical Center, Israel

    STUDY CHAIR

  • Ran Kornowski, Prof,MD

    Chairman, Dept. of Cardiology, Rabin Medical Center, Israel

    STUDY DIRECTOR

  • Uri Landes, MD

    Dept. of Cardiology, Rabin Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 9, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)