Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
FROST-HF
1 other identifier
interventional
230
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedNovember 23, 2018
November 1, 2018
2 years
November 14, 2018
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
6MWT
Six minute walk test at 12 months
12 months
Secondary Outcomes (4)
MACE
12 months
Cardiac death
12 months
Congestive heart failure (CHF)
12 months
Quality of Life (QOL)
12 months
Study Arms (2)
Control arm
SHAM COMPARATORSham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
AFR arm
EXPERIMENTALImplantation of Occlutech atrial flow regulator (AFR) device
Interventions
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Sinai Health Systemcollaborator
- University Health Network, Torontocollaborator
Study Sites (3)
St. Michael's hospital
Toronto, Ontario, M5B 1W8, Canada
Sinai Health System
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 23, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
April 30, 2021
Last Updated
November 23, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share