NCT02511912

Heart Failure (HF) Interatrial Shunt Study 1

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: V-Wave Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study, is to assess the safety and performance of an interatrial shunt when implanted in patients with severe chronic heart failure.

Detailed description

This is a prospective, non-randomized, open label, single-arm multi-center study assessing the performance and safety of the V-Wave inter-atrial unidirectional shunt when implanted in chronic heart failure patients with both reduced and preserved ejection fraction. The V-Wave Interatrial Unidirectional Shunt is designed to enable blood flow in a controlled manner from the left atrium to the right atrium in heart failure patients where clinical sequelae such as symptomatic pulmonary congestion due to high left atrial filling pressure is common. The objective of this study, is to assess the safety and performance of the V-Wave System when implanted in patients with severe chronic heart failure. In addition, this study is designed, in-part, to collect a portion of the clinical data needed in support of a US FDA pivotal IDE study application to be submitted at a later date. Up to 70 subjects with chronic ACC/AHA Stage C, NYHA functional class III or ambulatory class IV heart failure (HF), with reduced or preserved LV ejection fraction, who have a history of hospitalization for worsening HF or elevated ambulatory levels of BNP/NT-proBNP, in the setting of maximally tolerated guideline-directed HF drug and device therapy, will be enrolled in the study.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
PROCEDURE	V-Wave	The V-Wave shunt implantation procedure is a standard femoral venous access and inter-atrial septal puncture intervention. The shunt is placed through the Fossa Ovalis.

Timeline

• Start date: 2017-03-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2015-07-30
• Last updated: 2019-10-10

Locations

1 site across 1 country: Israel