VENUS-HF: SVC Occlusion in Subjects With Acute Decompensated Heart Failure

• Sponsor: Abiomed Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03836079
• Collaborator: (none)
• Enrollment: 60
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 51.1
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Safety and performance evaluation of the preCARDIA System for patients with ADHF.

Condition or Disease	Intervention/Treatment	Phase
Acute Decompensated Heart Failure; Acute Heart Failure; Congestive Heart Failure; Heart Diseases	Device: preCARDIA system	N/A

Detailed Description

The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
• Actual Study Start Date: Jul 31, 2019
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADHF Patients Treatment with preCARDIA System	Device: preCARDIA system; Intermittent occlusion of the SVC

Outcome Measures

Primary Outcome Measures

1. Freedom from Major Adverse Events through 30 days. [30 days]

   MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• NYHA Class III-IV heart failure

• Subjects with inadequate diuresis

• Stage C-D systolic heart failure

Exclusion Criteria:

• Active myocardial ischemia or acute coronary syndrome (ACS)

• Severe aortic or mitral valve insufficiency

• Severe peripheral vascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern	Chicago	Illinois	United States	60611
2	University of Chicago	Chicago	Illinois	United States	60637
3	Kansas University Medical Center	Kansas City	Kansas	United States	66160
4	Tufts Medical Center	Boston	Massachusetts	United States	02111
5	Providence Health & Services	Portland	Oregon	United States	97225
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	Houston Methodist	Houston	Texas	United States	77030

Sponsors and Collaborators

• Abiomed Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abiomed Inc.
• ClinicalTrials.gov Identifier: NCT03836079
• Other Study ID Numbers: 101773-002
• First Posted: Feb 11, 2019
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure; Heart Diseases

Study Results

No Results Posted as of Aug 18, 2022