A study to evaluate the DC Devices, Inc. IASD* System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

Completed

Conditions: Heart Failure
10019280

Registration Number: NL-OMON45159

Lead Sponsor: Corvia Medical, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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 < 20 mm Hg
5. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC
6. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
7. Trans-septal catheterization and femoral vein access is determined to be feasible

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 < 2.0 L/min/m2
c. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
d. Patient is on the cardiac transplant waiting list
4. Inability to perform 6 Minute Walk Test
5. Known significant coronary artery disease (stenosis >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 < 95% on room air
13. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
14. Right ventricular dysfunction, defined as
a. More than mild RV dysfunction as determined by TTE: OR
b. TAPSE < 1.4 cm: OR
c. RV volume * LV volume on echo estimate; OR
d. Echocardiographic or clinical evidence of congestive hepatopathy
15. Resting CVP > 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 <1, or in the opinion of the investigator
18. Currently participating in an investigational drug or device study. Note: Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials
19. Life expectancy less than 12 months for non-cardiovascular reasons
20. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
21. Known or suspected allergy to nickel
22. Fertile women
23. Currently requiring dialysis; or e-GFR <25ml/min
24. SABP >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is the percent of subjects who experience major<br /><br>adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke,<br /><br>MI; or subjects who experience a systemic embolic event (excluding pulmonary<br /><br>thromboembolism); or subjects who require surgical implant removal within 6<br /><br>months from day of implant.<br /><br><br /><br>The primary device performance endpoints are:<br /><br>* The percent of subjects who have successful device implantation, defined as<br /><br>deployment at the intended location during the index procedure<br /><br>* The percent of subjects with reduction of PCWP, and demonstration of left to<br /><br>right flow through the device at 6 months</p><br>

Secondary Outcome Measures