Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2022-11-17
2031-03-31
Brief Summary
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Detailed Description
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Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Patients will be evaluated at pre-specified time intervals and followed for 5 years.
All patients will be unblinded after the 24 month follow up visit.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Treatment
Participants randomized to the treatment arm will undergo a fluoroscopic and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and InterAtrial Shunt Device (IASD) System II implant procedure.
Corvia Atrial Shunt System / IASD System II
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.
Control
Participants randomized to the control arm will undergo fluoroscopy and intracardiac echocardiography from the femoral vein or transesophageal echocardiography, for examination of the atrial septum and left atrial appendage.
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.
Interventions
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Corvia Atrial Shunt System / IASD System II
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.
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.
Eligibility Criteria
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Inclusion Criteria
1. Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
2. New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
3. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months
2. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics
3. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction \< 30% in the 5 years prior.
4. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
1. Left Atrial (LA) diameter \> 4 cm; or
2. Diastolic LA volume \> 50 or LA volume index \> 28 ml/m2 or
3. Lateral e' \< 10 cm/s; or
4. e' \< 8 cm/s; or
5. Site determined elevated pulmonary capillary wedge pressure (PCWP) with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25 millimeters of mercury (mm Hg), and greater than RAP by ≥ 5 mm Hg.
6. Resting RAP ≤ 14 mmHg
7. Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) \< 1.75 Wood units
8. Age ≥ 40 years old
9. Participant has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the Institutional Review Board (IRB) or Ethics Committee (EC)
10. Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
11. Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.
Exclusion Criteria
1. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF
2. Cardiac index \< 2.0 L/min/m2
3. Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months
4. Patient is on the cardiac transplant waiting list.
2. Inability to perform 6-minute walk test (distance \< 50 meters), OR 6-minute walk test \> 600m
3. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain)
4. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:
1. More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR
2. TAPSE \< 1.4 cm; OR
3. Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR
4. Ultrasound or clinical evidence of congestive hepatopathy; OR
5. Evidence of RV dysfunction defined by TTE as an RV fractional area change \< 35%.
5. Any implanted cardiac rhythm device
6. Structural heart repair aortic valve replacement (AVR) or mitral valve replacement (MVR) (surgical or percutaneous) within the past 12 months; planned valve intervention in the next 3 months, or presence of hemodynamically significant valve disease as assessed by the site cardiologist and defined as:
1. Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or \> mild Mitral Stenosis (MS); OR
2. Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR
3. Aortic valve disease ≥ 2+ aortic regurgitation (AR) or \> moderate aortic stenosis (AS)
7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
8. Participants with existing or surgically closed (with a patch) atrial septal defects. Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded
9. Myocardial Infarction (MI) and/or percutaneous cardiac intervention within past 3 months; Coronary Artery Bypass Graft (CABG) surgery in past 3 months or any planned cardiac interventions in the 3 months following enrollment.
10. Known clinically significant un-revascularized coronary artery disease, defined as: coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia
11. Known clinically significant untreated carotid artery stenosis likely to require intervention
12. Atrial fibrillation with resting heart rate (HR) \> 100 beats-per-minute (BPM)
13. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
14. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
15. Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy
16. Anemia with Hemoglobin \< 10 g/dl
17. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 \<1Liter
18. Resting arterial oxygen saturation \< 95% on room air, \<93% when residing at high altitude
19. Currently requiring dialysis; or estimated glomerular filtration rate eGFR \< 25ml/min/1.73 m2 by chronic kidney disease (CKD) CKD-Epi equation
20. Systolic blood pressure \> 170 mm Hg at screening
21. Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
22. Participants on significant immunosuppressive treatment or on systemic steroid treatment
23. Life expectancy less than 12 months for known non-cardiovascular reasons
24. Known hypersensitivity to nickel or titanium
25. Women of childbearing potential
26. Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures
27. Body Mass Index (BMI) \> 45; BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely
28. Severe depression and/or anxiety
29. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
30. In the opinion of the investigator, the Participant is not an appropriate candidate for the study.
40 Years
ALL
No
Sponsors
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Corvia Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjiv Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Martin Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Memorial Regional Hospital
Hollywood, Florida, United States
NCH Naples
Naples, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Northside Hospital Gwinnett Campus
Lawrenceville, Georgia, United States
Wellstar Kennestone
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Endeavor Health-Northshore
Glenview, Illinois, United States
LSU Health Shreveport
Shreveport, Louisiana, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
UMass Memorial Hospital University Campus
Worcester, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell
New York, New York, United States
Christ Hospital
Cincinnati, Ohio, United States
University of Cincinatti Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic OH
Cleveland, Ohio, United States
Ohio State University Wexner medical Center
Columbus, Ohio, United States
St. Francis Hospital (Heart Hospital)
Tulsa, Oklahoma, United States
OHSU Hospital
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Cardiovascular Institute (CVI) Research
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
North Central Heart-Avera
Sioux Falls, South Dakota, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia Heart and Vascular
Morgantown, West Virginia, United States
St. Vincents Hospital
Darlinghurst, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
LKH University Clinic
Graz, , Austria
Onze-Lieve-Vrouwziekenhuis Aalst (OLV)
Aalst, , Belgium
St. Paul's Hospital Providence Health Care
Vancouver, British Columbia, Canada
Unity Health Toronto St. Michael's Hospital
Toronto, Ontario, Canada
University Heart Center Bad Krozingen
Bad Krozingen, , Germany
Kerckhoff Klinik
Bad Nauheim, , Germany
Hospital Charité - University Medicine Berlin
Berlin, , Germany
Vivantes Clinic Friedrichshain Berlin
Berlin, , Germany
DRK Clinics Berlin Koepenick
Berlin, , Germany
Unfallkrankenhaus Berlin
Berlin, , Germany
University Hospital Cologne
Cologne, , Germany
Heart Center of Dresden
Dresden, , Germany
UK Duesseldorf
Düsseldorf, , Germany
University Heart Center Freiburg
Freiburg im Breisgau, , Germany
Georg-August Universität Gottingen Universitätsklinikum Göttingen Klinik für Kardiologie und Pneumologie
Göttingen, , Germany
Marienkrankenhaus Hospital Hamburg
Hamburg, , Germany
Asklepios Clinic Altona Hamburg
Hamburg, , Germany
Herzzentrum Leipzig - Universitätsklinik
Leipzig, , Germany
University Hospital Schleswig-Holstein (UKSH) Luebeck
Lübeck, , Germany
University Hospital Münster
Münster, , Germany
Helios Kliniken Schwerin
Schwerin, , Germany
Ulm University Hospital
Ulm, , Germany
University Hospital Wurzburg
Würzburg, , Germany
UMCG - Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Vijendra Swarup, MD
Role: primary
Daniel Roshevsky
Role: primary
Role: backup
Annie Kellum
Role: primary
Anne Gordon
Role: primary
Maricel Roxas
Role: primary
Suzanna Barker
Role: primary
Ulrike Maier
Role: primary
Elisabetha Gharib
Role: primary
Anja Gerstendberg-Eschment
Role: primary
Sylke Helms
Role: primary
Ana Heinrichs
Role: primary
Cecile Bosredion
Role: primary
Marion Redlefsen
Role: primary
Christine Neumann
Role: primary
Josephine Koch
Role: primary
Rosa Saraei
Role: primary
Lena Makowski
Role: primary
Pauline Herke
Role: primary
Olga Smirnova
Role: primary
Victoria Sokalski
Role: primary
References
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Borlaug BA, Blair J, Bergmann MW, Bugger H, Burkhoff D, Bruch L, Celermajer DS, Claggett B, Cleland JGF, Cutlip DE, Dauber I, Eicher JC, Gao Q, Gorter TM, Gustafsson F, Hayward C, van der Heyden J, Hasenfuss G, Hummel SL, Kaye DM, Komtebedde J, Massaro JM, Mazurek JA, McKenzie S, Mehta SR, Petrie MC, Post MC, Nair A, Rieth A, Silvestry FE, Solomon SD, Trochu JN, Van Veldhuisen DJ, Westenfeld R, Leon MB, Shah SJ; REDUCE LAP-HF-II Investigators. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022 May 24;145(21):1592-1604. doi: 10.1161/CIRCULATIONAHA.122.059486. Epub 2022 Mar 31.
Shah SJ, Borlaug BA, Chung ES, Cutlip DE, Debonnaire P, Fail PS, Gao Q, Hasenfuss G, Kahwash R, Kaye DM, Litwin SE, Lurz P, Massaro JM, Mohan RC, Ricciardi MJ, Solomon SD, Sverdlov AL, Swarup V, van Veldhuisen DJ, Winkler S, Leon MB; REDUCE LAP-HF II investigators. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022 Mar 19;399(10330):1130-1140. doi: 10.1016/S0140-6736(22)00016-2. Epub 2022 Feb 1.
Other Identifiers
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2201
Identifier Type: -
Identifier Source: org_study_id
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