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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03751748
Recruitment Status : Unknown
Verified November 2018 by Unity Health Toronto.
Recruitment status was:  Not yet recruiting
First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Collaborators:
Sinai Health System
University Health Network, Toronto
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Device: AFR implantation Device: Sham procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, sham controlled, single blind with objective end points.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 6MWT [ Time Frame: 12 months ]
    Six minute walk test at 12 months


Secondary Outcome Measures :
  1. MACE [ Time Frame: 12 months ]
    Composite of cardiac death, heart failure hospitalization and worsening heart failure

  2. Cardiac death [ Time Frame: 12 months ]
    Death from a cardiac cause (myocardial infarction, sudden death)

  3. Congestive heart failure (CHF) [ Time Frame: 12 months ]
    Heart failure hospitalization, worsening heart failure

  4. Quality of Life (QOL) [ Time Frame: 12 months ]
    QOL as per KCCQE questionaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751748


Contacts
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Contact: Asim Cheema, MD, PhD 416-864-5739 cheemaa@smh.ca

Locations
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Canada, Ontario
St. Michael's hospital
Toronto, Ontario, Canada, M5B 1W8
Contact: Asim Cheema, MD    416-864-5739    cheemaA@smh.ca   
Principal Investigator: Asim Cheema, MD, FRCPC         
Principal Investigator: Abdul Alhesayen, MD, FRCPC         
Sinai Health System
Toronto, Ontario, Canada
Contact: Susanna Mak, MD, FRCPC         
Principal Investigator: Susanna Mak, MD, FRCPC         
University Health Network
Toronto, Ontario, Canada
Contact: Mark Osten, MD, FRCPC         
Principal Investigator: Mark Osten, MD, FRCPC         
Sponsors and Collaborators
Unity Health Toronto
Sinai Health System
University Health Network, Toronto
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03751748    
Other Study ID Numbers: AC201809
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases