Heart Failure With Normal Ejection Fraction
Conditions
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 provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.
Interventions
DEVICEAFR implantation
Implantation of atrial flow regulator (AFR) device
DEVICESham procedure
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Sponsors
Sinai Health System
University Health Network, Toronto
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Multicenter, randomized, sham controlled, single blind with objective end points.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6MWT | 12 months | Six minute walk test at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 months | Composite of cardiac death, heart failure hospitalization and worsening heart failure |
| Cardiac death | 12 months | Death from a cardiac cause (myocardial infarction, sudden death) |
| Congestive heart failure (CHF) | 12 months | Heart failure hospitalization, worsening heart failure |
| Quality of Life (QOL) | 12 months | QOL as per KCCQE questionaire |
Countries
Canada
Contacts
Primary ContactAsim Cheema, MD, PhD
Outcome results
None listed