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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
Date last updated
22/02/2023

Titles & IDs
Public title
REDUCE LAP-HF TRIAL II
Scientific title
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure
Secondary ID [1] 0 0
1601
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Primary Endpoint
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Composite safety endpoint defined as follows:
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Rate of heart failure admissions
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Change in NYHA Class
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Change in Kansas City Cardiomyopathy Questionnaire
Timepoint [4] 0 0
12 months

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
608
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
St. Vincent Hospital - Sydney
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corvia Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
Trial website
https://clinicaltrials.gov/study/NCT03088033
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.
Public notes

Contacts
Principal investigator
Name 0 0
Sanjiv Shah, MD
Address 0 0
Northwestern Memorial Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03088033