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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03088033




Registration number
NCT03088033
Ethics application status
Date submitted
14/03/2017
Date registered
23/03/2017
Date last updated
13/12/2019

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
Protocol 1601
Universal Trial Number (UTN)
Trial acronym
REDUCELAPHF II
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
12 Month Composite Primary Endpoint - 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) admissions or healthcare facility visits for IV diuresis for HF through 12 months and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Change in NYHA Class - Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Change in Kansas City Cardiomyopathy Questionnaire - Change in KCCQ score between baseline and 12 months
Timepoint [2] 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 5 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Austria
State/province [30] 0 0
Graz
Country [31] 0 0
Austria
State/province [31] 0 0
Vienna
Country [32] 0 0
Belgium
State/province [32] 0 0
Aalst
Country [33] 0 0
Belgium
State/province [33] 0 0
Brugge
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Montréal
Country [36] 0 0
Croatia
State/province [36] 0 0
Zagreb
Country [37] 0 0
Denmark
State/province [37] 0 0
Copenhagen
Country [38] 0 0
France
State/province [38] 0 0
Dijon
Country [39] 0 0
France
State/province [39] 0 0
Nantes
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
France
State/province [42] 0 0
Rouen
Country [43] 0 0
Germany
State/province [43] 0 0
Bad Nauheim
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Dusseldorf
Country [46] 0 0
Germany
State/province [46] 0 0
Freiburg
Country [47] 0 0
Germany
State/province [47] 0 0
Gottingen
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Heidelberg
Country [50] 0 0
Germany
State/province [50] 0 0
Homburg
Country [51] 0 0
Germany
State/province [51] 0 0
Kiel
Country [52] 0 0
Germany
State/province [52] 0 0
Leipzig
Country [53] 0 0
Germany
State/province [53] 0 0
Munich
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Japan
State/province [55] 0 0
Hokkaido
Country [56] 0 0
Japan
State/province [56] 0 0
Fukuoka
Country [57] 0 0
Japan
State/province [57] 0 0
Hyogo
Country [58] 0 0
Japan
State/province [58] 0 0
Nara
Country [59] 0 0
Japan
State/province [59] 0 0
Osaka
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
Country [61] 0 0
Japan
State/province [61] 0 0
Tottori
Country [62] 0 0
Japan
State/province [62] 0 0
Toyama
Country [63] 0 0
Netherlands
State/province [63] 0 0
Amsterdam
Country [64] 0 0
Netherlands
State/province [64] 0 0
Groningen
Country [65] 0 0
Netherlands
State/province [65] 0 0
Maastricht
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nieuwegein
Country [67] 0 0
Poland
State/province [67] 0 0
Wroclaw
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Belfast
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Glasgow
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London

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/show/NCT03088033
Trial related presentations / publications
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
Jan Komtebedde, DVM
Address 0 0
Country 0 0
Phone 0 0
978-654-6113
Fax 0 0
Email 0 0
jkomtebedde@corviamedical.com
Contact person for scientific queries

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