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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01913613




Registration number
NCT01913613
Ethics application status
Date submitted
30/07/2013
Date registered
1/08/2013
Date last updated
15/07/2020

Titles & IDs
Public title
REDUCE LAP-HF TRIAL
Scientific title
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
Secondary ID [1] 0 0
2013-01
Universal Trial Number (UTN)
Trial acronym
REDUCE LAP-HF
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

Experimental: Treatment - Treatment with the IASD device


Treatment: Devices: IASD
IASD device implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MACCE
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
Key

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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2018
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
David Kaye - Melbourne
Recruitment hospital [3] 0 0
St. Vincent Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Czechia
State/province [4] 0 0
Prague
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Germany
State/province [10] 0 0
Dusseldorf
Country [11] 0 0
Germany
State/province [11] 0 0
Gottingen
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Germany
State/province [13] 0 0
Heidelberg
Country [14] 0 0
Germany
State/province [14] 0 0
Kiel
Country [15] 0 0
Germany
State/province [15] 0 0
Munich
Country [16] 0 0
Netherlands
State/province [16] 0 0
Nieuwegein
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Poland
State/province [18] 0 0
Wroclaw
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Glasgow
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Harefield
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corvia Medical
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01913613
Trial related presentations / publications
Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.
Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.
Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.
Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.
Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.
Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.
Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.
Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.
Public notes

Contacts
Principal investigator
Name 0 0
Jan Komtebedde, DVM
Address 0 0
Corvia Medical
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/NCT01913613