Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05652218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002037', 'term': 'Bundle-Branch Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'single arm crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in myocardial performance index (MPI) as compared to Baseline', 'timeFrame': 'Baseline and 3 month treatment period after each pacing mode', 'description': 'Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Left Ventricular Ejection Fraction', 'Heart Failure (HF)', 'Left Bundle-Branch Block']}, 'descriptionModule': {'briefSummary': 'Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF \\> 35%, and LBBB.', 'detailedDescription': 'This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (\\>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female aged ≥18 years\n* Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads.\n* NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic\n* LVEF \\>35% by clinically obtained echocardiogram overread by the study core-lab\n* Demonstration of adequate echocardiographic images to allow for assessment of endpoints\n* On a stable guideline directed HF medical regimen\n* For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation\n* Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.\n\nExclusion Criteria:\n\n* Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study\n* Treatment with another investigational drug or other intervention within 3 months\n* Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months\n* Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)\n* Significant structural heart \\[including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)\\]\n* Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg)\n* Oxygen dependent chronic lung disease\n* Prolonged episodes of AF (\\>3 days or an AF burden \\>10%) within the preceding 3 months\n* Presence of cardiac pacemaker or implantable cardioverter defibrillator\n* Prior mechanical tricuspid valve replacement\n* Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus\n* Known allergic reactions to components of the pacemaker or leads\n* Febrile illness within 3 days of trial enrollment\n* Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n* Control Participant Exclusion Criteria: same'}, 'identificationModule': {'nctId': 'NCT05652218', 'acronym': 'REINVENT', 'briefTitle': 'REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'U22-04-4739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group', 'interventionNames': ['Device: LB-CRT', 'Device: BIV-CRT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group', 'interventionNames': ['Device: LB-CRT', 'Device: BIV-CRT']}], 'interventions': [{'name': 'LB-CRT', 'type': 'DEVICE', 'description': 'LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'BIV-CRT', 'type': 'DEVICE', 'description': 'BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Brett Atwater, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Health Care Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}