Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group. All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization. Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II 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
608
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 the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
Time frame: Up to 24 months
Composite safety endpoint defined as follows:
1. Cardiovascular mortality 2. Non-fatal, ischemic stroke 3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min) 4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery 5. Thrombo-embolic complications (TIA, systemic embolization) 6. Newly acquired persistent or permanent AF or atrial flutter through 7. ≥30% increase in RV size/decrease in TAPSE
Time frame: 12 months
Rate of heart failure admissions
Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up
Time frame: Up to 24 months
Change in NYHA Class
Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
Time frame: 12 months
Change in Kansas City Cardiomyopathy Questionnaire
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Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Kaiser Permanente San Diego
La Jolla, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Yale University
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
...and 81 more locations
Change in KCCQ score between baseline and 12 months, categorized as ≤0, \>0 - 5, \>5 - 10, \>10 - 15, \>15 - 20, \>20 - 25, \>25.
Time frame: 12 months