REDUCE LAP-HF TRIAL (REDUCE LAP-HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01913613 |
Recruitment Status :
Completed
First Posted : August 1, 2013
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Device: IASD | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Treatment with the IASD device
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Device: IASD
IASD device implantation |
- MACCE [ Time Frame: 6 months ]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)

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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%
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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 Criteria:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913613

Study Chair: | Jan Komtebedde, DVM | Corvia Medical |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Corvia Medical |
ClinicalTrials.gov Identifier: | NCT01913613 |
Other Study ID Numbers: |
2013-01 |
First Posted: | August 1, 2013 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
Heart Failure Heart Diseases Cardiovascular Diseases |