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

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

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

Study Overview

• Status: Unknown
• Conditions: Heart Failure With Normal Ejection Fraction
• Intervention / Treatment: Device: Sham procedure; Device: AFR implantation

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 Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asim Cheema, MD, PhD; Phone Number: 416-864-5739; Email: cheemaa@smh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
      • Contact: Asim Cheema, MD; Phone Number: 416-864-5739; Email: cheemaA@smh.ca
      • Principal Investigator: Asim Cheema, MD, FRCPC
      • Principal Investigator: Abdul Alhesayen, MD, FRCPC
    • Toronto, Ontario, Canada
      • University Health Network
      • Contact: Mark Osten, MD, FRCPC
      • Principal Investigator: Mark Osten, MD, FRCPC
    • Toronto, Ontario, Canada
      • Sinai Health System
      • Contact: Susanna Mak, MD, FRCPC
      • Principal Investigator: Susanna Mak, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University Health Network, Toronto; Sinai Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AC201809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No