Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
NCT ID: NCT03751748
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
230 participants
INTERVENTIONAL
2019-01-01
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control arm
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Sham procedure
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
AFR arm
Implantation of Occlutech atrial flow regulator (AFR) device
AFR implantation
Implantation of atrial flow regulator (AFR) device
Interventions
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AFR implantation
Implantation of atrial flow regulator (AFR) device
Sham procedure
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sinai Health System
OTHER
University Health Network, Toronto
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Locations
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St. Michael's hospital
Toronto, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Susanna Mak, MD, FRCPC
Role: primary
Mark Osten, MD, FRCPC
Role: primary
Other Identifiers
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AC201809
Identifier Type: -
Identifier Source: org_study_id
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