Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 12:24 AM
Study NCT ID:
NCT03278418
Status:
UNKNOWN
Last Update Posted:
2017-09-11
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant TR (moderate or severe)', 'timeFrame': '3 years', 'description': 'To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (\\>10 cm2).'}], 'secondaryOutcomes': [{'measure': 'Significant TR (moderate or severe)', 'timeFrame': '1 and 2 years', 'description': 'To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (\\>10 cm2).'}, {'measure': 'Mild TR', 'timeFrame': '1,2 and 3 years', 'description': 'To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2) or mild (\\<5 cm2).'}, {'measure': 'Overall TR (mild, moderate, severe)', 'timeFrame': '1, 2 and 3 years', 'description': 'To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2; mild \\<5 cm2, moderate = 5-10 cm2), or severe (\\>10 cm2).'}, {'measure': 'RV function', 'timeFrame': '1, 2 and 3 years', 'description': 'To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters.'}, {'measure': 'Pulmonary Artery Pressure (PAP)', 'timeFrame': '1, 2 and 3 years', 'description': 'To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)'}, {'measure': 'Event free survival', 'timeFrame': '3 years', 'description': 'Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.', 'detailedDescription': 'The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.\n\nPatients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.\n\nAfter discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing left-sided valve surgery for left-sided valve disease\n* Presence of non-severe TR and tricuspid annular dilation (\\>40 mm or \\> 21 mm/m2 BSA) determined by echocardiography\n* Age ≥ 18 years\n* Capability to sign Informed Consent and Release of Medical Information forms\n\nExclusion Criteria:\n\n* Preoperative severe TR\n* Structural / organic tricuspid valve disease\n* Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE\n* Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV\n* Any type of reoperative surgery\n* Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)\n* Cardiogenic shock at the time of randomization\n* ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization\n* Evidence of cirrhosis or hepatic synthetic failure\n* Severe, irreversible pulmonary hypertension in the judgment of the investigator\n* Pregnancy at the time of randomization\n* Any concurrent disease with life expectancy \\< 1 year\n* Patient unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03278418', 'acronym': 'RIGHT', 'briefTitle': 'Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach', 'organization': {'class': 'OTHER', 'fullName': 'Ettore Sansavini Health Science Foundation'}, 'officialTitle': 'Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'ESREFO 32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tricuspid Valve Repair', 'description': 'Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery', 'interventionNames': ['Procedure: Tricuspid Valve Repair', 'Procedure: Left-sided valve surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'left-sided valve surgery', 'description': 'No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery', 'interventionNames': ['Procedure: Left-sided valve surgery']}], 'interventions': [{'name': 'Tricuspid Valve Repair', 'type': 'PROCEDURE', 'description': 'It will be performed according to the surgeon preference', 'armGroupLabels': ['Tricuspid Valve Repair']}, {'name': 'Left-sided valve surgery', 'type': 'PROCEDURE', 'description': 'It will be performed according to the surgeon preference', 'armGroupLabels': ['Tricuspid Valve Repair', 'left-sided valve surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48033', 'city': 'Cotignola', 'state': 'Ravenna', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'zip': '20097', 'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Frigiola, MD, PhD', 'role': 'CONTACT', 'email': 'alessandro.frigiola@grupposandonato.it', 'phone': '+390252774392'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Ottavio Alfieri, MD, PhD', 'role': 'CONTACT', 'email': 'cardiochirurgia@hsr.it', 'phone': '+390226437102'}], 'facility': 'IRCCS Opsedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '90135', 'city': 'Palermo', 'country': 'Italy', 'contacts': [{'name': 'Khalil Fattouch, MD, PhD', 'role': 'CONTACT', 'email': 'khalilfattouch@hotmail.com', 'phone': '+393288105584'}], 'facility': 'Maria Eleonora Hospital', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'centralContacts': [{'name': 'Mauro Del Giglio, MD', 'role': 'CONTACT', 'email': 'mdelgiglio@gvmnet.it', 'phone': '+390545217445'}, {'name': 'Donato Mele, MD', 'role': 'CONTACT', 'email': 'donatomele@libero.it', 'phone': '+393476411190'}], 'overallOfficials': [{'name': 'Maria Salomone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ettore Sansavini Health Science Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}