Status:
UNKNOWN
Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Sinai Health System
University Health Network, Toronto
Conditions:
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03751748
Start Date
January 1 2019
End Date
April 30 2021
Last Update
November 23 2018
Active Locations (3)
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1
St. Michael's hospital
Toronto, Ontario, Canada, M5B 1W8
2
Sinai Health System
Toronto, Ontario, Canada
3
University Health Network
Toronto, Ontario, Canada