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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425459
Other study ID # 2201
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 17, 2022
Est. completion date March 2031

Study information

Verified date February 2024
Source Corvia Medical
Contact Jan Komtebedde, DVM
Phone 978-654-6113
Email jkomtebedde@corviamedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization


Description:

Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date March 2031
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Chronic symptomatic heart failure (HF) documented by the following: 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. Advanced heart failure defined as one or more of the below: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
Other:
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.

Locations

Country Name City State
Australia Prince Charles Hospital Chermside Queensland
Australia St. Vincents Hospital Darlinghurst New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia John Hunter Hospital New Lambton Heights New South Wales
Austria LKH University Clinic Graz
Belgium Onze-Lieve-Vrouwziekenhuis Aalst (OLV) Aalst
Germany Kerckhoff Klinik Bad Nauheim
Germany Unfallkrankenhaus Berlin Berlin
Germany UK Duesseldorf Duesseldorf
Germany University Heart Center Freiburg Freiburg
Germany Georg-August Universität Gottingen Universitätsklinikum Göttingen Klinik für Kardiologie und Pneumologie Göttingen
Netherlands UMCG - Groningen Groningen
Netherlands Maastricht University Medical Center Maastricht
United States University of Michigan Health Systems Ann Arbor Michigan
United States Ascension Seton Medical Center Austin Texas
United States Lahey Hospital & Medical Center Burlington Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Christ Hospital Cincinnati Ohio
United States Cleveland Clinic OH Cleveland Ohio
United States Ohio State University Wexner medical Center Columbus Ohio
United States Cardiovascular Institute of the South (CIS) Houma Louisiana
United States Baylor St. Luke's Medical Center Houston Texas
United States Scripps Clinic La Jolla California
United States West Virginia Heart and Vascular Morgantown West Virginia
United States NCH Naples Naples Florida
United States Vanderbilt University Nashville Tennessee
United States Weill Cornell New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Cardiovascular Research Center Phoenix Arizona
United States Mayo Clinic Rochester Rochester Minnesota
United States Sarasota Memorial Hospital (Intercoastal Medical Group) Sarasota Florida
United States LSU Health Shreveport Shreveport Louisiana
United States St. Francis Hospital (Heart Hospital) Tulsa Oklahoma
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Corvia Medical

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Germany,  Netherlands, 

References & Publications (2)

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. Erratum In: Circulation. 2022 Jul 26;146(4):e12. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Composite Primary Endpoint The primary endpoint is a composite of heart failure event rates and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months.
Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health.
Up to 12 months
Secondary The incidence of cardiovascular mortality The incidence of cardiovascular mortality through 12 months. Up to 12 months
Secondary The rate of time-to-cardiovascular mortality Time-to-cardiovascular mortality through 12 months. Up to 12 months
Secondary The rate of major adverse cardiac periprocedural events Major adverse cardiac periprocedural events through 30 days defined as:
Cardiac death
Myocardial infarction
Cardiac tamponade
Emergency cardiac surgery.
Through 30 days
Secondary The incidence of non-fatal, ischemic stroke Incidence of non-fatal, ischemic stroke Through 12 months
Secondary The rate of new onset or worsening of kidney dysfunction New onset or worsening of kidney dysfunction (defined as estimated glomerular filtration rate (eGFR) decrease of > 20 ml/min/1.73 m2) through 12 months Through 12 months
Secondary The incidence of thrombo-embolic complications including transient ischaemic attack (TIA) and systemic embolization) The incidence of thrombo-embolic complications (TIA and systemic embolization) through 12 months Through 12 months
Secondary The incidence of newly acquired persistent or permanent atrial fibrillation (AF) or atrial flutter The incidence of newly acquired persistent or permanent AF or atrial flutter Through 12 months
Secondary The incidence of participants with a =30% decrease in Tricuspid Annular Plane Systolic Excursion (TAPSE) The incidence of participants with a =30% decrease Tricuspid Annular Plane Systolic Excursion (TAPSE) Through 12 months
Secondary The rate of heart failure (HF) admissions Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for intravenous diuresis or urgent visits with intensification of oral diuresis for HF through 24 months, analyzed when the last randomized participant completes 12 months follow-up. Through 24 months
Secondary The change in New York Heart Association (NYHA) Class Change in NYHA functional Class between baseline and 12 months 12 months
Secondary The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score between baseline and 12 months, categorized as proportion of patients with changes of =0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25 points. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health 12 months
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