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Heart FailureREDUCE LAP-HFNCT01913613

REDUCE LAP-HF TRIAL

A study testing IASD in people with Heart Failure, run by Corvia Medical at 26 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure
What is being tested?
IASD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
26 sitesin 11 countries
Study dates
Sep 2013to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
  • 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;
  • 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);
  • 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%
Show all 9Show fewer
  • Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
  • PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
  • PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Who cannot join

  • 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

Trial locations and contacts

26 sites in 11 countries.

26 sites in 11 countries

Germany7 sites

  • Universitatklinikum Duseldorf

    Düsseldorf

  • Georg-August-Universitat

    Göttingen

  • Asklepios Klinik St George

    Hamburg

  • Cardiologicum CRC

    Hamburg

  • University of Heidelberg

    Heidelberg

  • Universtitaät Kliniku Schlewig Holstein

    Kiel

  • Klinikum der Universität Munchen

    Munich

Other trials in Germany

France5 sites

  • CHRU de Lille

    Lille

  • CHU de Nantes

    Nantes

  • Hôpital Bichat

    Paris

  • Hôpital La Pitié Salpétrière

    Paris

  • Hôpital Rangueil

    Toulouse

Other trials in France

Australia3 sites

  • The Prince Charles Hospital

    Brisbane

  • David Kaye

    Melbourne

  • St. Vincent Hospital

    Sydney

Other trials in Australia

United Kingdom3 sites

  • Golden Jubilee Hospital

    Glasgow

  • Royal Brompton/Harefield Trust

    Harefield

  • King's College

    London

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universität Graz

    Graz

  • Allgemeines Krankenhaus Univesitäts Kliniken

    Vienna

Other trials in Austria

Belgium1 site

  • OLVZ Aalst

    Aalst

Other trials in Belgium

Czechia1 site

  • Homolka Hospital

    Prague

Other trials in Czechia

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Netherlands1 site

  • St Antonius Ziekenhuis

    Nieuwegein

Other trials in Netherlands

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

Poland1 site

  • Fourth Military Hospital

    Wroclaw

Other trials in Poland

About this study

Official 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

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.

Conditions
Heart Failure
Being tested
IASD
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IASDDevice

    IASD device implantation

Study groups in NCT01913613
Study groupRoleWhat they receive
TreatmentExperimentalTreatment with the IASD device
Receives: Device: IASD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE

    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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01913613
Sponsor's protocol ID
2013-01
Acronym
REDUCE LAP-HF
Status last verified
Jul 2020
First submitted
30 Jul 2013
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26055211

  • 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.

    PubMed 27025436

  • 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.

    PubMed 27852653

  • 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.

    PubMed 28949052

  • 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.

    PubMed 30311437

  • 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.

    PubMed 30354556

  • 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.

    PubMed 31653352

  • 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.

    PubMed 31753198

Questions about this trial

What is this clinical trial studying?

A study testing IASD in people with Heart Failure, run by Corvia Medical at 26 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, France, Australia, United Kingdom, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01913613, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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