Clinical trial · Observational
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aortic Valve Stenosis | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Native aortic valve | Device | — | UNRESOLVED |
| Transcatheter aortic valve implantation (TAVI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TAVI Patients with active cancer
- description
- Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
- interventionNames
- Device: Native aortic valve
- Procedure: Transcatheter aortic valve implantation (TAVI)
- label
- TAVI patients without cancer
- description
- Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves.
- interventionNames
- Device: Native aortic valve
- Procedure: Transcatheter aortic valve implantation (TAVI)
Primary outcomes (1)
- measure
- Patients survival
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDSwain 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 23602601
- BACKGROUNDNishimura 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 28315732
- BACKGROUNDNishimura 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 24603191
- DERIVEDLandes 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 30621982