Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

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

Detailed Description
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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.

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

Conditions
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Heart Failure With Normal Ejection Fraction

Intervention / Treatment
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* Device: AFR implantation
* Device: Sham procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, sham controlled, single blind with objective end points.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control arm<br>Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo | Device: Sham procedure<br>* Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo<br>|
| Experimental: AFR arm<br>Implantation of Occlutech atrial flow regulator (AFR) device | Device: AFR implantation<br>* Implantation of atrial flow regulator (AFR) device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | Six minute walk test at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Composite of cardiac death, heart failure hospitalization and worsening heart failure | 12 months | 
| Cardiac death | Death from a cardiac cause (myocardial infarction, sudden death) | 12 months | 
| Congestive heart failure (CHF) | Heart failure hospitalization, worsening heart failure | 12 months | 
| Quality of Life (QOL) | QOL as per KCCQE questionaire | 12 months |