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Heart FailureNCT02600234

REDUCE LAP-HF RANDOMIZED TRIAL I

A study testing Inter-Atrial Shunt Device and Intracardiac Echo in people with Heart Failure, run by Corvia Medical at 21 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure. 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?
Inter-Atrial Shunt Device and Intracardiac Echo
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
21 sitesin 5 countries
Study dates
Dec 2015to Aug 2026
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
  • Ongoing stable GDMT HF management and management of potential comorbidities
  • Age ≥ 40 years old
  • LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
  • Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Who cannot join

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
  • Cardiac Resynchronization Therapy initiated within the past 6 months
  • Severe heart failure
  • 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
  • Known clinically significant untreated carotid artery stenosis
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States17 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 41809

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Medical University of South Carolina

    Charleston, South Carolina

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio Health

    Columbus, Ohio

  • Ohio State University College of Medicine

    Columbus, Ohio

  • Evanston Northshore Healthcare

    Evanston, Illinois, 60201

  • Cardiovascular Institute of the South

    Houma, Louisiana

  • Yale University

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center/NewYork Presbyterian Hospital

    New York, New York

  • Mt. Sinai Hospital

    New York, New York

  • New York University

    New York, New York

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Arizona College of Medicine

    Tucson, Arizona, 85724

  • Wake Forest

    Winston-Salem, North Carolina

Other trials in United States

Australia1 site

  • The Alfred Hospital

    Melbourne

Other trials in Australia

Belgium1 site

  • OLVZ Aalst

    Aalst

Other trials in Belgium

Netherlands1 site

  • UMC Groningen

    Groningen

Other trials in Netherlands

United Kingdom1 site

  • Golden Jubilee Hospital

    Glasgow

Other trials in United Kingdom

About this study

Official title: REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Read the detailed description

The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

Conditions
Heart Failure
Being tested
Inter-Atrial Shunt Device, Intracardiac Echo
Medical subject headings
Heart Failure

What participants receive

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

  • Inter-Atrial Shunt DeviceDevice

    Also called IASD

    An implantable device placed in the interatrial septum

  • Intracardiac EchoOther

    Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.

Study groups in NCT02600234
Study groupRoleWhat they receive
Treatment with Inter-Atrial Shunt DeviceExperimentalOnce all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Receives: Device: Inter-Atrial Shunt Device
ControlPlacebo comparatorOnce all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.
Receives: Other: Intracardiac Echo

What is being measured

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

  1. Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)

    The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as:

    1. Cardiovascular death through 1-month post implant;
    2. Embolic stroke through 1-months post implant;
    3. Device and or procedure related adverse cardiac events through 1-month post implant;
    4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 1-month post implant

    Measured: 1 Month Post Implant

  2. Change in supine exercise pulmonary capillary wedge pressure (PCWP)

    Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).

    Measured: 1 Month Post Implant

Secondary outcomes (5)

  1. Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline

    Measured: 1 Month

  2. Cardiovascular death

    Measured: 12 Months

  3. Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF

    Measured: 12 Months

  4. Change in Quality Of Life Questionnaire (EQ-5D)

    Measured: 12 Months

  5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)

    Measured: 12 Months

Timeline

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

  1. First posted9 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016
  4. Study completionAug 2026 (estimated)

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
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600234
Sponsor's protocol ID
1501
Status last verified
Jun 2022
First submitted
5 Nov 2015
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Litwin SE, Komtebedde J, Borlaug BA, Kaye DM, Hasenfubeta G, Kawash R, Hoendermis E, Hummel SL, Cikes M, Gustafsson F, Chung ES, Mohan RC, Sverdlov AL, Swarup V, Winkler S, Hayward CS, Bergmann MW, Bugger H, McKenzie S, Nair A, Rieth A, Burkhoff D, Cutlip DE, Solomon SD, van Veldhuisen DJ, Leon MB, Shah SJ. Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials. Am Heart J. 2024 Dec;278:106-116. doi: 10.1016/j.ahj.2024.08.014. Epub 2024 Sep 3.

    PubMed 39237070

  • 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

  • Shah SJ, Feldman T, Ricciardi MJ, Kahwash R, Lilly S, Litwin S, Nielsen CD, van der Harst P, Hoendermis E, Penicka M, Bartunek J, Fail PS, Kaye DM, Walton A, Petrie MC, Walker N, Basuray A, Yakubov S, Hummel SL, Chetcuti S, Forde-McLean R, Herrmann HC, Burkhoff D, Massaro JM, Cleland JGF, Mauri L. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):968-977. doi: 10.1001/jamacardio.2018.2936.

    PubMed 30167646

  • Feldman T, Mauri L, Kahwash R, Litwin S, Ricciardi MJ, van der Harst P, Penicka M, Fail PS, Kaye DM, Petrie MC, Basuray A, Hummel SL, Forde-McLean R, Nielsen CD, Lilly S, Massaro JM, Burkhoff D, Shah SJ; REDUCE LAP-HF I Investigators and Study Coordinators. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial. Circulation. 2018 Jan 23;137(4):364-375. doi: 10.1161/CIRCULATIONAHA.117.032094. Epub 2017 Nov 15.

    PubMed 29142012

  • Feldman T, Komtebedde J, Burkhoff D, Massaro J, Maurer MS, Leon MB, Kaye D, Silvestry FE, Cleland JG, Kitzman D, Kubo SH, Van Veldhuisen DJ, Kleber F, Trochu JN, Auricchio A, Gustafsson F, Hasenfubeta G, Ponikowski P, Filippatos G, Mauri L, Shah SJ. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I). Circ Heart Fail. 2016 Jul;9(7):e003025. doi: 10.1161/CIRCHEARTFAILURE.116.003025.

    PubMed 27330010

Questions about this trial

What is this clinical trial studying?

A study testing Inter-Atrial Shunt Device and Intracardiac Echo in people with Heart Failure, run by Corvia Medical at 21 sites in 5 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Australia, Belgium, Netherlands, United Kingdom. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) (time frame: 1 Month Post Implant). The study lists 2 primary outcomes in all. 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 NCT02600234, which also lists 5 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 10 Mar 2023.

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