Heart Failure
Conditions
Brief summary
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
Detailed description
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction \>40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.
Interventions
DEVICEInter-Atrial Shunt Device
An implantable device placed in the interatrial septum
OTHERIntracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.
Sponsors
Corvia Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic symptomatic Heart Failure * Ongoing stable GDMT HF management and management of potential comorbidities * Age ≥ 40 years old * LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction \<30%. * Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg Key
Exclusion criteria
* MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization * Cardiac Resynchronization Therapy initiated within the past 6 months * Severe heart failure * Inability to perform 6 minute walk test (distance \< 50 m), OR 6 minute walk test \> 600m * History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months * Presence of significant valve disease * Known clinically significant untreated carotid artery stenosis * Currently requiring dialysis; or estimated-GFR \<25ml/min/1.73 m2 by CKD-Epi equation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) | 1 Month Post Implant | The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as: 1. Cardiovascular death through 1-month post implant; 2. Embolic stroke through 1-months post implant; 3. Device and or procedure related adverse cardiac events through 1-month post implant; 4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min) through 1-month post implant |
| Change in supine exercise pulmonary capillary wedge pressure (PCWP) | 1 Month Post Implant | Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W). |
Secondary
| Measure | Time frame |
|---|---|
| Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF | 12 Months |
| Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline | 1 Month |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) | 12 Months |
| Change in Quality Of Life Questionnaire (EQ-5D) | 12 Months |
| Cardiovascular death | 12 Months |
Countries
Australia, Belgium, Netherlands, United Kingdom, United States
Outcome results
None listed