Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT04334694
Status:
UNKNOWN
Last Update Posted:
2020-04-06
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Flow Regulator in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pulmonary artery wedge pressure (PAWP) at rest', 'timeFrame': '30 days after AFR', 'description': 'Reduction of PAWP at rest'}, {'measure': 'Pulmonary artery wedge pressure (PAWP) during handgrip test', 'timeFrame': '30 days after AFR', 'description': 'Reduction of PAWP during handgrip test'}, {'measure': 'KCCQ-12', 'timeFrame': '12 months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ-12)'}, {'measure': 'Clinical adverse event', 'timeFrame': '12 months', 'description': 'Cardiac mortality'}, {'measure': 'Clinical adverse event II', 'timeFrame': '12 months', 'description': 'Rehospitalization for HF decompensation'}], 'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '12 months', 'description': 'Increase in 6 minutes walk test distance'}], 'secondaryOutcomes': [{'measure': 'Clinical improvement II', 'timeFrame': '12 months', 'description': 'Reduction in New York Heart Association (NYHA) class'}, {'measure': 'Device related adverse event', 'timeFrame': '12 months', 'description': 'Device migration, embolization, device related thrombus, shunt occlusion, need for device removal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial flow regulator; heart failure; interatrial shunting'], 'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptomatic heart failure (HF) in NYHA class III or IV ambulatory\n* Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months\n* Hospitalization because of HF decompensation in last 12 months\n* Absence of significant valvular disease requiring cardiac surgery\n* Life expectancy ≥ 1 year\n* Written informed consent obtained from the patient\n* Left ventricle ejection fraction (LVEF) ≥ 15%\n* Elevated left heart filling pressures:\n\n 1. Pulmonary artery wedge pressure (PAWP) at rest \\> 15 mmHg or\n 2. PAWP \\> 25 mmHg during hand grip test\n\nExclusion Criteria:\n\n* Participation in another clinical trial in last 30 days\n* Acute infection or sepsis\n* Severe coagulation disorder\n* Allergy to nickel or titanium\n* Severe peripheral artery disease disabling 6 minutes walk test\n* Allergy to antiplatelet drugs, oral anticoagulants or heparin\n* Contraindication to trans-oesophageal echocardiography (TEE)\n* Pregnancy\n* Atrial septal defect (ASD) or presence of atrial septal occluder\n* Severe patent foramen ovale (PFO) with significant left to right shunt in rest\n* Intracardiac thrombus\n* Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months\n* Severe pulmonary hypertension:\n\n 1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)\n 2. Right atrial pressure \\> 20 mmHg (measured in right heart catheterization)\n* Planned heart transplantation\n* Transient ischemic attack or stroke within last 6 months\n* Cardiac resynchronisation therapy (CRT) within last 6 months'}, 'identificationModule': {'nctId': 'NCT04334694', 'acronym': 'PROLONGER', 'briefTitle': 'Atrial Flow Regulator in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Szpitale Pomorskie Sp. z o. o.'}, 'officialTitle': 'Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial', 'orgStudyIdInfo': {'id': '01/2020/W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Atrial flow regulator', 'description': 'In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).', 'interventionNames': ['Device: Atrial flow regulator (Occlutech® AFR device)']}], 'interventions': [{'name': 'Atrial flow regulator (Occlutech® AFR device)', 'type': 'DEVICE', 'description': 'Atrial septostomy followed by implantation of AFR.', 'armGroupLabels': ['Atrial flow regulator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84-200', 'city': 'Wejherowo', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lukasz Lewicki, MD,PhD', 'role': 'CONTACT', 'email': 'luklewicki@gmail.com', 'phone': '+48501702885'}, {'name': 'Maciej Karwowski, MD', 'role': 'CONTACT', 'email': 'maciejkarwowskimd@gmail.com', 'phone': '+48500473983'}, {'name': 'Lukasz Lewicki, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maciej Karwowski, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastian Liedtke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katarzyna Kosmalska, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marek Szolkiewicz, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kashubian Cardiovascular Center', 'geoPoint': {'lat': 54.60568, 'lon': 18.23559}}], 'centralContacts': [{'name': 'Lukasz Lewicki, MD, PhD', 'role': 'CONTACT', 'email': 'luklewicki@gmail.com', 'phone': '+48501702885'}, {'name': 'Maciej Karwowski, MD', 'role': 'CONTACT', 'email': 'maciejkarwowskimd@gmail.com', 'phone': '+48500473983'}], 'overallOfficials': [{'name': 'Lukasz Lewicki, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kashubian Cardiovascular Center; University Center for Cardiology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available after completion of the study.', 'ipdSharing': 'YES', 'description': 'The following data will be available:\n\n* echocardiography reports\n* right heart catheterization reports\n* clinical and demographic data', 'accessCriteria': 'The data will be shared on personal request for review process.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szpitale Pomorskie Sp. z o. o.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}