Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Rare Diseases

Constriction, Pathologic

Aortic Valve Stenosis

Pathological Conditions, Anatomical

Aortic Valve Disease

Heart Valve Diseases

Heart Diseases

Ventricular Outflow Obstruction

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

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

Native valve, with any transcatheter heart valve type

Native aortic valve

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

Transcatheter aortic valve implantation (TAVI)

Ran Kornowski, Prof,MD

Uri Landes, MD

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.

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.

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

Provides information regarding patients functional status on scale of 1-4.

Whether the cause of death is cardiovascular or non-cardiovascular.

Rabin Medical Center

Principal Investigator

Neoplasms

Atrial Fibrillation

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Arrhythmias, Cardiac

Heart Neoplasms

Ischemia

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Thoracic Neoplasms

Heart Tumor

Patients undergoing aortic valve replacement

Patients undergoing cardiac surgery for indication other than above

Cardiac surgery

Tuomas O Kiviniemi, MD, PhD

Jarmo Gunn, MD, PhD

The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.

The investigators aim to A) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events B) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples C) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.

Atrial appendage, valves, ascending aorta, pericardium

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis	NCT03181997	Aortic Valve St... Malignancy	Native aortic v... Transcatheter a...	-	Rabin Medical Center
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients	NCT03444259	Atrial Fibrilla... Coronary Artery... Aortic Valve St... Aortic Valve Di... Mitral Valve Di... Cardiac Arrythm... Cardiac Tumor Cardiac Surgery	Cardiac surgery	18 Years -	University of Turku

Spots Global Cancer Trial Database for aortic valve stenosis