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

Not Applicable

• Conditions: Heart Failure With Normal Ejection Fraction
• Interventions: Device: AFR implantation; Device: Sham procedure

• Registration Number: NCT03751748
• Lead Sponsor: Unity Health Toronto

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23
• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFR arm	AFR implantation	Implantation of Occlutech atrial flow regulator (AFR) device
Control arm	Sham procedure	Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo

Primary Outcome Measures

Name	Time	Method
6MWT	12 months	Six minute walk test at 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

St. Michael's hospital; 🇨🇦 Toronto, Ontario, Canada

Sinai Health System; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada