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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03088033
Registration number
NCT03088033
Ethics application status
Date submitted
14/03/2017
Date registered
23/03/2017
Titles & IDs
Public title
REDUCE LAP-HF TRIAL II
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Scientific title
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure
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Secondary ID [1]
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1601
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - IASD System II implant
Other interventions - intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Experimental: Treatment - Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.
Sham comparator: Control - Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Treatment: Devices: IASD System II implant
The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
Other interventions: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite Primary Endpoint
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Assessment method [1]
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The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
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Timepoint [1]
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Up to 24 months
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Secondary outcome [1]
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Composite safety endpoint defined as follows:
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Assessment method [1]
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1. Cardiovascular mortality
2. Non-fatal, ischemic stroke
3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min)
4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery
5. Thrombo-embolic complications (TIA, systemic embolization)
6. Newly acquired persistent or permanent AF or atrial flutter through
7. =30% increase in RV size/decrease in TAPSE
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Rate of heart failure admissions
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Assessment method [2]
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Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up
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Timepoint [2]
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Up to 24 months
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Secondary outcome [3]
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Change in NYHA Class
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Assessment method [3]
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Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Change in Kansas City Cardiomyopathy Questionnaire
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Assessment method [4]
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Change in KCCQ score between baseline and 12 months, categorized as =0, \>0 - 5, \>5 - 10, \>10 - 15, \>15 - 20, \>20 - 25, \>25.
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Timepoint [4]
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12 months
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Eligibility
Key inclusion criteria
SELECT INCLUSION CRITERIA
* Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
* Symptoms of HF requiring current treatment with diuretics for = 30 days AND
* NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
* = 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
* Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months
* Age = 40 years old, LV ejection fraction (EF) = 40% within the past 3 months, without previously documented EF <30% (within the past 3 years)
* Elevated PCWP with a gradient compared to right atrial pressure (RAP), documented by end-expiratory PCWP during supine ergometer exercise = 25mmHg, and greater than RAP by = 5 mmHg
SELECT EXCLUSION CRITERIA
* MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
* Cardiac Resynchronization Therapy initiated within the past 6 months
* Advanced heart failure defined as one or more of the below:
* ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF;
* Cardiac index < 2.0 L/min/m2
* Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months
* Patient is on the cardiac transplant waiting list
* Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
* Presence of significant valve disease defined by the site cardiologist as:
* Mitral valve regurgitation defined as grade = 3+ MR
* Tricuspid valve regurgitation defined as grade = 2+ TR
* Aortic valve disease defined as = 2+ AR or > moderate AS
* Known clinically significant untreated carotid artery stenosis likely to require intervention
* Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
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Minimum age
40
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
608
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Hospital - Camperdown
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Royal Prince Alfred Hospital - Camperdown
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John Hunter Hospital - Newcastle
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St. Vincent Hospital - Sydney
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The Prince Charles Hospital - Brisbane
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The Alfred Hospital - Melbourne
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2050 - Camperdown
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2305 - Newcastle
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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4032 - Brisbane
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Corvia Medical
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
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Trial website
https://clinicaltrials.gov/study/NCT03088033
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Trial related presentations / publications
Shah SJ, Borlaug BA, Chung ES, Cutlip DE, Debonnaire P, Fail PS, Gao Q, Hasenfuss G, Kahwash R, Kaye DM, Litwin SE, Lurz P, Massaro JM, Mohan RC, Ricciardi MJ, Solomon SD, Sverdlov AL, Swarup V, van Veldhuisen DJ, Winkler S, Leon MB; REDUCE LAP-HF II investigators. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022 Mar 19;399(10330):1130-1140. doi: 10.1016/S0140-6736(22)00016-2. Epub 2022 Feb 1.
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Public notes
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Contacts
Principal investigator
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Sanjiv Shah, MD
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Address
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Northwestern Memorial Hospital
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03088033