Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-27 @ 9:35 AM
Study NCT ID:
NCT02600234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-10
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDUCE LAP-HF RANDOMIZED TRIAL I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)', 'timeFrame': '1 Month Post Implant', 'description': '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:\n\n1. Cardiovascular death through 1-month post implant;\n2. Embolic stroke through 1-months post implant;\n3. Device and or procedure related adverse cardiac events through 1-month post implant;\n4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \\> 20 ml/min) through 1-month post implant'}, {'measure': 'Change in supine exercise pulmonary capillary wedge pressure (PCWP)', 'timeFrame': '1 Month Post Implant', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline', 'timeFrame': '1 Month'}, {'measure': 'Cardiovascular death', 'timeFrame': '12 Months'}, {'measure': 'Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF', 'timeFrame': '12 Months'}, {'measure': 'Change in Quality Of Life Questionnaire (EQ-5D)', 'timeFrame': '12 Months'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39237070', 'type': 'DERIVED', 'citation': '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': '31753198', 'type': 'DERIVED', 'citation': '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': '30167646', 'type': 'DERIVED', 'citation': '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': '29142012', 'type': 'DERIVED', 'citation': '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': '27330010', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Chronic symptomatic Heart Failure\n* Ongoing stable GDMT HF management and management of potential comorbidities\n* Age ≥ 40 years old\n* LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction \\<30%.\n* 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\n\nKey Exclusion Criteria:\n\n* MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization\n* Cardiac Resynchronization Therapy initiated within the past 6 months\n* Severe heart failure\n* Inability to perform 6 minute walk test (distance \\< 50 m), OR 6 minute walk test \\> 600m\n* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months\n* Presence of significant valve disease\n* Known clinically significant untreated carotid artery stenosis\n* Currently requiring dialysis; or estimated-GFR \\<25ml/min/1.73 m2 by CKD-Epi equation'}, 'identificationModule': {'nctId': 'NCT02600234', 'briefTitle': 'REDUCE LAP-HF RANDOMIZED TRIAL I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corvia Medical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Inter-Atrial Shunt Device', 'description': 'Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.', 'interventionNames': ['Device: Inter-Atrial Shunt Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Other: Intracardiac Echo']}], 'interventions': [{'name': 'Inter-Atrial Shunt Device', 'type': 'DEVICE', 'otherNames': ['IASD'], 'description': 'An implantable device placed in the interatrial septum', 'armGroupLabels': ['Treatment with Inter-Atrial Shunt Device']}, {'name': 'Intracardiac Echo', 'type': 'OTHER', 'description': 'Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northshore Healthcare', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '41809', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/NewYork Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University College of Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLVZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'UMC Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Golden Jubilee Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Sanjiv Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corvia Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}