Clinical trial NCT03181997: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Malignancy
Keywords: Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Cancer
Malignancy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be selected from several international transcatheter aortic valve implantation centers.

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.

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.

Primary outcomes:
measure: Patients survival
timeFrame: 2 years
Secondary outcomes:
measure: New York Heart Association Functional Classification (NYHA FC)
timeFrame: 2 years
measure: Cause of death
timeFrame: 2 years
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center,
Study officials:
affiliation: Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
name: Ran Kornowski, Prof,MD
role: STUDY_CHAIR
affiliation: Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
name: Ran Kornowski, Prof,MD
role: STUDY_DIRECTOR
affiliation: Dept. of Cardiology, Rabin Medical Center, Israel
name: Uri Landes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.