Heart Failure With Normal Ejection FractionFROST-HFNCT03751748
Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
A study testing AFR implantation in people with Heart Failure With Normal Ejection Fraction, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- What is being tested?
- AFR implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Michael's hospital
Toronto, Ontario, M5B 1W8
Asim Cheema, MD, 416-864-5739, cheemaA@smh.ca
Asim Cheema, MD, FRCPC
Sinai Health System
Toronto, Ontario
Susanna Mak, MD, FRCPC
Susanna Mak, MD, FRCPC
University Health Network
Toronto, Ontario
Mark Osten, MD, FRCPC
Mark Osten, MD, FRCPC
About this study
Official title: 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.
Read the 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.
- Being tested
- AFR implantation, Sham procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFR implantationDevice
Implantation of atrial flow regulator (AFR) device
Sham procedureDevice
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Sham comparator | Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo Receives: Device: Sham procedure |
| AFR arm | Experimental | Implantation of Occlutech atrial flow regulator (AFR) device Receives: Device: AFR implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
Six minute walk test at 12 months
Measured: 12 months
Secondary outcomes (4)
MACE
Composite of cardiac death, heart failure hospitalization and worsening heart failure
Measured: 12 months
Cardiac death
Death from a cardiac cause (myocardial infarction, sudden death)
Measured: 12 months
Congestive heart failure (CHF)
Heart failure hospitalization, worsening heart failure
Measured: 12 months
Quality of Life (QOL)
QOL as per KCCQE questionaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, sham controlled, single blind with objective end points.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System, University Health Network, Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751748
- Sponsor's protocol ID
- AC201809
- Acronym
- FROST-HF
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
- ClinicalTrials.gov ID
- NCT03751748
- Acronym / sponsor ID
- FROST-HF / AC201809
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sinai Health System, University Health Network, Toronto
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, sham controlled, single blind with objective end points.
| Arm | Type | Receives |
|---|---|---|
| Control arm | Sham comparator | Device: Sham procedureSham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo |
| AFR arm | Experimental | Device: AFR implantationImplantation of Occlutech atrial flow regulator (AFR) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFR implantationImplantation of atrial flow regulator (AFR) device | Device | AFR arm |
| Sham procedureSham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo | Device | Control arm |
Primary outcome
6MWT
Time frame: 12 months
Six minute walk test at 12 months
4 secondary outcomes
MACE
Time frame: 12 months
Cardiac death
Time frame: 12 months
Congestive heart failure (CHF)
Time frame: 12 months
Quality of Life (QOL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFR implantation in people with Heart Failure With Normal Ejection Fraction, run by Unity Health Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asim Cheema, MD, PhD (416-864-5739, cheemaa@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.