Heart Failure (HF) Interatrial Shunt Study 1

NCT02511912 | Withdrawn DMC

• 1 other identifier: HF Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Freedom from study-related Major Adverse Cardiac and Neurological Events (MACNE)

  MACNE is defined as the hierarchical composite of death, stroke, myocardial infarction, systemic embolic event or the requirement for surgical removal of the Study Device.

  6 months

Study Arms (1)

V-Wave

EXPERIMENTAL

This is a single arm study, all eligible patients will receive the V-Wave implantable shunt. The V-Wave device is implanted via standard femoral venous access and inter-atrial septal puncture intervention and is placed through the Fossa Ovalis.

Procedure: V-Wave

Interventions

V-Wave PROCEDURE

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.

V-Wave

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months
• ACC/AHA Stage C, NYHA Class III or ambulatory Class IV heart failure,
• Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines
• Subject has a minimum of one (1) prior hospital admission within the last 12 months for acute worsening of HF associated with signs/symptoms of congestion
• Able to perform the 6-minute walk test with a distance ≥150 meters and ≤450 meters.
• Provide written informed consent for study participation

You may not qualify if:

• Age \<18 or \>85 years old
• BMI \<18 or \>40 kg/m2
• systolic blood pressure \<90 or \>160 mmHg
• Has baseline 2-D echocardiographic evidence of, or history of, unresolved or non- organized intracardiac thrombus
• Has Pulmonary Hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
• Significant RV dysfunction defined echocardiographically as TAPSE \<12mm or RVFAC ≤30%.
• Left Ventricular End-Diastolic Diameter (LVEDD) \> 8cm
• Has an Atrial Septal Defect or Patent Foramen Ovale with more than trace shunting on color Doppler or intravenous bubble study or prior surgical or interventional correction of congenital heart disease involving atrial septum including placement of a PFO or ASD closure device
• Had a Stroke, Transient Ischemic Attack, Systemic or Pulmonary Thromboembolism, or Deep Vein Thrombosis (DVT) within the last 6 months, or any prior stroke with permanent neurologic defect.
• Has untreated severe stenotic or regurgitant valve lesions, or coronary stenoses which are anticipated to require surgical or percutaneous intervention within 6 months, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as cause of HF.
• Transseptal procedure is anticipated within 6 months after the V-Wave Shunt implant.
• Bradycardia with heart rate \<45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmias.
• Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D).
• Intolerant to both ACEI and ARB and beta-blocker medical therapy for patients classified as HFrEF (EF ≤40%).
• Had an acute MI, Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Rhythm Management system revision, lead extraction, or cardiac or other major surgery within 30 days.

Sponsors & Collaborators

• V-Wave Ltd: lead

Study Sites (1)

V-Wave Ltd.

Caesarea Industrial Park (North), 3088900, Israel

Location

Study Officials

• Olivia Mishall

  V-Wave Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 30, 2015
• Study Start: March 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 10, 2019

Record last verified: 2016-11

Locations

IL (1)