REDUCE LAP-HF RANDOMIZED TRIAL I

NCT02600234 | Active Not Recruiting DMC

• 1 other identifier: 1501
• Study Type: interventional
• Target: 44
• Locations: 5 countries
• Sites: 21

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  1 Month Post Implant

• 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).

  1 Month Post Implant

Secondary Outcomes (5)

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

  1 Month

• Cardiovascular death

  12 Months

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

  12 Months

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

  12 Months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)

  12 Months

Study Arms (2)

Treatment with Inter-Atrial Shunt Device

EXPERIMENTAL

Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.

Device: Inter-Atrial Shunt Device

Control

PLACEBO COMPARATOR

Once 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.

Other: Intracardiac Echo

Interventions

Inter-Atrial Shunt Device DEVICE

An implantable device placed in the interatrial septum

Also known as: IASD

Treatment with Inter-Atrial Shunt Device

Intracardiac Echo OTHER

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

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corvia Medical: lead

Study Sites (21)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Evanston Northshore Healthcare

Evanston, Illinois, 60201, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 41809, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, United States

Location

Mt. Sinai Hospital

New York, New York, United States

Location

New York University

New York, New York, United States

Location

Wake Forest

Winston-Salem, North Carolina, United States

Location

Ohio Health

Columbus, Ohio, United States

Location

Ohio State University College of Medicine

Columbus, Ohio, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

The Alfred Hospital

Melbourne, Australia

Location

OLVZ Aalst

Aalst, Belgium

Location

UMC Groningen

Groningen, Netherlands

Location

Golden Jubilee Hospital

Glasgow, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 39237070 DERIVED

• 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.

  PMID: 31753198 DERIVED

• 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.

  PMID: 30167646 DERIVED

• 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.

  PMID: 29142012 DERIVED

• 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.

  PMID: 27330010 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sanjiv Shah, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 10, 2023

Record last verified: 2022-06

Locations

NL (1); GB (1); BE (1); AU (1); US (17)