Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath. Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Patients will be evaluated at pre-specified time intervals and followed for 5 years. All patients will be unblinded after the 24 month follow up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
750
The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
Composite Primary Endpoint
The primary endpoint is a composite of heart failure event rates and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health.
Time frame: Up to 12 months
The incidence of cardiovascular mortality
The incidence of cardiovascular mortality through 12 months.
Time frame: Up to 12 months
The rate of time-to-cardiovascular mortality
Time-to-cardiovascular mortality through 12 months.
Time frame: Up to 12 months
The rate of major adverse cardiac periprocedural events
Major adverse cardiac periprocedural events through 30 days defined as: 1. Cardiac death 2. Myocardial infarction 3. Cardiac tamponade 4. Emergency cardiac surgery.
Time frame: Through 30 days
The incidence of non-fatal, ischemic stroke
Incidence of non-fatal, ischemic stroke
Time frame: Through 12 months
The rate of new onset or worsening of kidney dysfunction
New onset or worsening of kidney dysfunction (defined as estimated glomerular filtration rate (eGFR) decrease of \> 20 ml/min/1.73 m2) through 12 months
Time frame: Through 12 months
The incidence of thrombo-embolic complications including transient ischaemic attack (TIA) and systemic embolization)
The incidence of thrombo-embolic complications (TIA and systemic embolization) through 12 months
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Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
RECRUITINGScripps Clinic
La Jolla, California, United States
RECRUITINGMemorialCare Long Beach Medical Center
Long Beach, California, United States
RECRUITINGChristiana Care Health Services
Newark, Delaware, United States
RECRUITINGMemorial Regional Hospital
Hollywood, Florida, United States
RECRUITINGNCH Naples
Naples, Florida, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGNorthside Hospital Gwinnett Campus
Lawrenceville, Georgia, United States
RECRUITINGWellstar Kennestone
Marietta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITING...and 51 more locations
Time frame: Through 12 months
The incidence of newly acquired persistent or permanent atrial fibrillation (AF) or atrial flutter
The incidence of newly acquired persistent or permanent AF or atrial flutter
Time frame: Through 12 months
The incidence of participants with a ≥30% decrease in Tricuspid Annular Plane Systolic Excursion (TAPSE)
The incidence of participants with a ≥30% decrease Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: Through 12 months
The rate of heart failure (HF) admissions
Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for intravenous diuresis or urgent visits with intensification of oral diuresis for HF through 24 months, analyzed when the last randomized participant completes 12 months follow-up.
Time frame: Through 24 months
The change in New York Heart Association (NYHA) Class
Change in NYHA functional Class between baseline and 12 months
Time frame: 12 months
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score between baseline and 12 months, categorized as proportion of patients with changes of ≤0, \>0 - 5, \>5 - 10, \>10 - 15, \>15 - 20, \>20 - 25, \>25 points. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health
Time frame: 12 months