Status:
COMPLETED
REDUCE LAP-HF TRIAL
Lead Sponsor:
Corvia Medical
Conditions:
Heart Failure
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomat...
Eligibility Criteria
Inclusion
- Key
- Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- 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;
- 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);
- 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).
- Age ≥ 40 years old
- Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
- Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
- PCWP during supine bike exercise ≥ 25mm Hg, and CVP \< 20 mm Hg
- Key
Exclusion
- 3\. Severe heart failure defined as:
- ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- Fick Cardiac Index \< 2.0 L/min/m2
- Requiring inotropic infusion (continuous or intermittent) within the past 6 months
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01913613
Start Date
September 1 2013
End Date
July 1 2018
Last Update
July 15 2020
Active Locations (26)
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1
The Prince Charles Hospital
Brisbane, Australia
2
David Kaye
Melbourne, Australia
3
St. Vincent Hospital
Sydney, Australia
4
Medizinische Universität Graz
Graz, Austria