Flow Regulation by Opening the Septum in Patients With Heart Failure Trial (FROST-HF)

Unity Health Toronto

Status: Unknown

Conditions: Heart Failure With Normal Ejection Fraction

Treatments: Device: AFR implantation; Device: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03751748

AC201809

Details and patient eligibility

About

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

Full description

The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• Age > 40 years
• LVEF > 45% documented within the last 3 months.
• NYHA class ≥II status or 6MWT distance <80% predicted.
• Left atrial enlargement
• PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.
• Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic monitoring.

Exclusion criteria

• Recent MI, PCI or CABG
• Untreated CAD with indication for revascularization
• Recent stroke, pulmonary embolism or major surgery
• Uncontrolled atrial fibrillation
• H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease
• Inability to perform a 6-minute walk test.
• Clinically significant valvular disease
• Uunsuitable for study participation at investigator discretion.
• Severe COPD, Anemia or morbid obesity
• Uncontrolled hypertension
• Women of child bearing age
• RA pressure >15 mmHg or PVR >4 wood units

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

Control arm

Sham Comparator group

Description:

Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo

Treatment:

Device: Sham procedure

AFR arm

Experimental group

Description:

Implantation of Occlutech atrial flow regulator (AFR) device

Treatment:

Device: AFR implantation