REDUCE LAP-HF TRIAL (REDUCE LAP-HF)

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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

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

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:

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).
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 :
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:

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

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

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