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

Primary Purpose

Heart Failure With Normal Ejection Fraction

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
AFR implantation
Sham procedure
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Michael's hospital
  • Sinai Health System
  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control arm

AFR arm

Arm Description

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

Implantation of Occlutech atrial flow regulator (AFR) device

Outcomes

Primary Outcome Measures

6MWT
Six minute walk test at 12 months

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2018
Last Updated
November 21, 2018
Sponsor
Unity Health Toronto
Collaborators
Sinai Health System, University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03751748
Brief Title
Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
Acronym
FROST-HF
Official Title
Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Sinai Health System, University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Normal Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, sham controlled, single blind with objective end points.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Sham Comparator
Arm Description
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Arm Title
AFR arm
Arm Type
Experimental
Arm Description
Implantation of Occlutech atrial flow regulator (AFR) device
Intervention Type
Device
Intervention Name(s)
AFR implantation
Intervention Description
Implantation of atrial flow regulator (AFR) device
Intervention Type
Device
Intervention Name(s)
Sham procedure
Intervention Description
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Primary Outcome Measure Information:
Title
6MWT
Description
Six minute walk test at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MACE
Description
Composite of cardiac death, heart failure hospitalization and worsening heart failure
Time Frame
12 months
Title
Cardiac death
Description
Death from a cardiac cause (myocardial infarction, sudden death)
Time Frame
12 months
Title
Congestive heart failure (CHF)
Description
Heart failure hospitalization, worsening heart failure
Time Frame
12 months
Title
Quality of Life (QOL)
Description
QOL as per KCCQE questionaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asim Cheema, MD, PhD
Phone
416-864-5739
Email
cheemaa@smh.ca
Facility Information:
Facility Name
St. Michael's hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asim Cheema, MD
Phone
416-864-5739
Email
cheemaA@smh.ca
First Name & Middle Initial & Last Name & Degree
Asim Cheema, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Abdul Alhesayen, MD, FRCPC
Facility Name
Sinai Health System
City
Toronto
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanna Mak, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Susanna Mak, MD, FRCPC
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Osten, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Mark Osten, MD, FRCPC

12. IPD Sharing Statement

Plan to Share IPD
No

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

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