Clinical trial NCT04414332: Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry
Official title: Registry of Angiovac Procedures In Detail Outcomes Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolic Disease
Deep Venous Thrombosis
Right Heart Pathology
Pulmonary Embolism
Keywords: inferior vena cava (IVC) clots
right atrial (RA) masses
pulmonary emboli (PE)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 18 years and older in whom the Angiovac device was deployed.

Brief summary: Venous thromboembolic disease is a significant cause of morbidity and mortality. The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.

Detailed description: Venous thromboembolic disease is a significant cause of morbidity and mortality. Thrombolytic therapy has been shown to be a successful treatment modality, however its use is somewhat limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial hemorrhage), and suggested risk of distal embolization where large mobile thrombi are encountered. In patients where either thrombolysis is contraindicated or unsuccessful and conventional therapies inadequate, bulk thrombectomy may be considered. Until recently this was primarily achieved with surgical thrombectomy; however the Angiovac device is posited to offer a minimally invasive alternative.

This registry will collect data on patients in whom the Angiovac device was placed into the body for management of inferior vena cava (IVC) clots, right atrial (RA) masses or pulmonary emboli (PE) will be included.

This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.

Any center performing Angiovac procedure and wishing to contribute patient data will be offered participation in the registry. These core sites will be required to submit the registry protocol for Institutional Review Board (IRB) review. Once documentation of IRB approval has been received, centers may transmit their data via secure REDCap (Research Electronic Data Capture) database in accordance with federal regulations in the Health Insurance Portability and Accountability Act (HIPAA

Eligibility criteria: Inclusion Criteria:

* All patients in whom the Angiovac device was placed into the body for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Exclusion Criteria:

* Angiovac device not deployed

Primary outcomes:
measure: Post procedure outcomes
timeFrame: Procedure and up to 24 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: John Moriarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moriarty JM, Liao M, Kim GHJ, Yang E, Desai K, Ranade M, Plotnik AN. Procedural outcomes associated with use of the AngioVac System for right heart thrombi: A safety report from RAPID registry data. Vasc Med. 2022 Jun;27(3):277-282. doi: 10.1177/1358863X211073974. Epub 2022 Feb 17.