Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry

NCT04414332 | Completed

• 1 other identifier: 2015-SEP-1 Amendment 5
• Study Type: observational
• Target: 234
• Locations: 0 countries
• Sites: N/A

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.

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)

Outcome Measures

Primary Outcomes (1)

• Post procedure outcomes

  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.

  Procedure and up to 24 hours post procedure

Interventions

Data collection only OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ages 18 years and older in whom the Angiovac device was deployed.

You may qualify if:

• 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.

You may not qualify if:

• Angiovac device not deployed

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (1)

• 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.

  PMID: 35176918 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• John Moriarty, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2015
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: as per individual contract