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Trial record 2 of 8 for:    IASD

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

Tracking Information
First Submitted Date  ICMJE July 30, 2013
First Posted Date  ICMJE August 1, 2013
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REDUCE LAP-HF TRIAL
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: IASD
IASD device implantation
Study Arms  ICMJE Experimental: Treatment
Treatment with the IASD device
Intervention: Device: IASD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2018)
64
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   Denmark,   France,   Germany,   Netherlands,   New Zealand,   Poland,   United Kingdom
Removed Location Countries Czech Republic,   Greece,   India,   Israel
 
Administrative Information
NCT Number  ICMJE NCT01913613
Other Study ID Numbers  ICMJE 2013-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corvia Medical
Study Sponsor  ICMJE Corvia Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jan Komtebedde, DVM Corvia Medical
PRS Account Corvia Medical
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP