Heart Failure
Conditions
Interventions
Percutaneous implantation (permanent) of the IAS System II.
Sponsors
Corvia Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Candidates for the study must meet ALL of the following inclusion criteria: 1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following: a. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; b. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify); c. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure). 2. Age * 40 years old 3. Left ventricular ejection fraction (obtained by echocardiography) * 40% 4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by : a. PCWP (end expiratory) or LVEDP (end expiratory) at rest * 15 mmHg, and greater than CVP, OR b. PCWP (end expiratory) during supine bike exercise * 25mm Hg, and CVP
Exclusion criteria
Exclusion criteria: Candidates for this study will be excluded if ANY of the following conditions are present: 1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization 2. Cardiac Resynchronization Therapy initiated within the past 6 months 3. Severe heart failure defined as: a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; b. Cardiac Index 70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade * 2+ TR; c) Aortic valve disease defined as * 2+ AR or moderate AS 9. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac Amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, Sarcoidosis) 10. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy 11. Atrial fibrillation with resting HR > 100 BPM 12. Arterial Oxygen saturation 14 mmHg 16. Evidence of pulmonary hypertension with PVR > 4 Woods Units (mm Hg/L/min) 17. Chronic pulmonary disease requiring home oxygen, OR hospitalization for exacerbation in the 6 months prior to study entry, OR significant chronic pulmonary disease defined either as FEV1 170 despite appropriate medical management 25. Subjects in whom trans-esophageal echocardiography (TEE) is contraindicated 26. Subjects with existing Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed. 27. Subjects on immunosuppression or systemic steroid treatment (>10 mg prednisone/day) 28. Subjects who have diagnosed scleroderma 29. In the opinion of the investigator, the subject is not an appropriate candidate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism); or subjects who require surgical implant removal within 6 months from day of implant. The primary device performance endpoints are: * The percent of subjects who have successful device implantation, defined as deployment at the intended location during the index procedure * The percent of subjects with reduction of PCWP, and demonstration of left to right flow through the device at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of major adverse cardiac events through 6-months post implant 2. Incidence of all serious adverse events (SAEs) through 6-months post implant 3. All-cause, and heart failure related hospitalizations; and number of hospitalization days, ICU days, through 6 months 4. All-cause mortality, CV mortality and heart failure related mortality through 6 months 5. Changes in invasive and noninvasive hemodynamic measures (at rest and when performed at baseline, also during exercise) assessed compared to baseline at 6 months by a core laboratory. a. The percent of patients with reduction of PCWP below the baseline value at rest and during exercise; b. Changes in pulmonary and systemic cardiac output; and in PA pressures 6. Changes in BNP and/or NT-pro-BNP assessed at 6 months compared to baseline 7. Changes in Investigator assessed NYHA classification assessed at 6 months compared to baseline 8. Changes in RA, LA, LV and RV dimensions, volume, and function as measured by echocardiography, assessed compared to baseline at 6 months by a core laboratory 9. Improvement in Quality of Life (QOL) as measure by Minnesota Living with Heart Failure Questionnaire (MLWHFQ) assessed at 6 months compared to baseline 10. Improvement in QOL as measured by EQ-5D-3L assessed compared to baseline at 6 months 11. Incidence of cerebrovascular events, through 6-months post implant 12. The percent of subjects with an improvement in exercise tolerance as assessed by 6MWT at 6 months compared to baseline 13. Incidence of newly acquired atrial arrhythmia, through 6-months post implant 14. Incidence of new onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 6-months post implant 15. Implant embolization and clinically significant device migration, defined as serious adverse event(s) probably related to device migration | — |
Countries
Netherlands
Outcome results
None listed