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REDUCE LAP-HF TRIAL (REDUCE LAP-HF)

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
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Study Description
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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 symptomatic despite appropriate medical management.

Condition or disease Intervention/treatment Phase
Heart Failure Device: IASD Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Treatment with the IASD device
 Device: IASD
IASD device implantation


Outcome Measures
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Primary Outcome Measures :
  1. 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)


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

Key Inclusion Criteria:

  1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

    1. 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;
    2. 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);
    3. 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 :

    1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
    2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:

3. Severe heart failure defined as:

  1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
  2. Fick Cardiac Index < 2.0 L/min/m2
  3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
  4. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Corvia Medical
Investigators
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Study Chair: Jan Komtebedde, DVM Corvia Medical
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases