Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 11:02 AM
Study NCT ID:
NCT01528657
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular pacing percentage', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Long-term atrio-ventricular conduction delay', 'timeFrame': '6 Months'}, {'measure': 'Occurrence of atrial tachycardia or atrial fibrillation events', 'timeFrame': '6 Months'}, {'measure': 'Burden of atrial fibrillation', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sick Sinus Syndrome', 'Ventricular pacing', 'Minimal ventricular pacing', 'Ventricular pacing suppression', 'Intrinsic rhythm support', 'Long term AV'], 'conditions': ['Sick Sinus Syndrome']}, 'referencesModule': {'references': [{'pmid': '3711479', 'type': 'BACKGROUND', 'citation': 'Vassallo JA, Cassidy DM, Miller JM, Buxton AE, Marchlinski FE, Josephson ME. Left ventricular endocardial activation during right ventricular pacing: effect of underlying heart disease. J Am Coll Cardiol. 1986 Jun;7(6):1228-33. doi: 10.1016/s0735-1097(86)80140-1.'}, {'pmid': '11991375', 'type': 'BACKGROUND', 'citation': 'Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x.'}, {'pmid': '2386214', 'type': 'BACKGROUND', 'citation': 'Prinzen FW, Augustijn CH, Arts T, Allessie MA, Reneman RS. Redistribution of myocardial fiber strain and blood flow by asynchronous activation. Am J Physiol. 1990 Aug;259(2 Pt 2):H300-8. doi: 10.1152/ajpheart.1990.259.2.H300.'}, {'pmid': '15583083', 'type': 'BACKGROUND', 'citation': 'Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jais P, Haissaguerre M, Clementy J, Jimenez M. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation. 2004 Dec 21;110(25):3766-72. doi: 10.1161/01.CIR.0000150336.86033.8D. Epub 2004 Dec 6.'}, {'pmid': '15489094', 'type': 'BACKGROUND', 'citation': 'Kanzaki H, Bazaz R, Schwartzman D, Dohi K, Sade LE, Gorcsan J 3rd. A mechanism for immediate reduction in mitral regurgitation after cardiac resynchronization therapy: insights from mechanical activation strain mapping. J Am Coll Cardiol. 2004 Oct 19;44(8):1619-25. doi: 10.1016/j.jacc.2004.07.036.'}, {'pmid': '6707363', 'type': 'BACKGROUND', 'citation': 'Maurer G, Torres MA, Corday E, Haendchen RV, Meerbaum S. Two-dimensional echocardiographic contrast assessment of pacing-induced mitral regurgitation: relation to altered regional left ventricular function. J Am Coll Cardiol. 1984 Apr;3(4):986-91. doi: 10.1016/s0735-1097(84)80357-5.'}, {'pmid': '9358483', 'type': 'BACKGROUND', 'citation': 'Vanderheyden M, Goethals M, Anguera I, Nellens P, Andries E, Brugada J, Brugada P. Hemodynamic deterioration following radiofrequency ablation of the atrioventricular conduction system. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2422-8. doi: 10.1111/j.1540-8159.1997.tb06081.x.'}, {'pmid': '12932590', 'type': 'BACKGROUND', 'citation': 'Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23. doi: 10.1016/s0735-1097(03)00757-5.'}, {'pmid': '9529267', 'type': 'BACKGROUND', 'citation': 'Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. doi: 10.1161/01.cir.97.10.987.'}, {'pmid': '15519023', 'type': 'BACKGROUND', 'citation': 'Nahlawi M, Waligora M, Spies SM, Bonow RO, Kadish AH, Goldberger JJ. Left ventricular function during and after right ventricular pacing. J Am Coll Cardiol. 2004 Nov 2;44(9):1883-8. doi: 10.1016/j.jacc.2004.06.074.'}, {'pmid': '12782566', 'type': 'BACKGROUND', 'citation': 'Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.'}, {'pmid': '29759604', 'type': 'DERIVED', 'citation': 'Calvi V, Pisano EC, Brieda M, Melissano D, Castaldi B, Guastaferro C, Nigro G, Madalosso M, Orsida D, Rovai N, Gargaro A, Capucci A. Atrioventricular Interval Extension Is Highly Efficient in Preventing Unnecessary Right Ventricular Pacing in Sinus Node Disease: A Randomized Cross-Over Study Versus Dual- to Atrial Single-Chamber Mode Switch. JACC Clin Electrophysiol. 2017 May;3(5):482-490. doi: 10.1016/j.jacep.2016.11.011. Epub 2017 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Patient has proven informed consent;\n* Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;\n* Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;\n* Stable medical situation;\n* Stable geographical situation;\n\nExclusion Criteria:\n\n* Permanent or paroxysmal AV block ≥ II;\n* Permanent Atrial fibrillation/Atrial flutter;\n* Device Replacement;\n* Patient with a poor echocardiographic window;\n* Patient already implanted with the right ventricular lead not in the apical position;\n* Subjects with a dual chamber pacemaker, implanted later than six months;\n* Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;\n* Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;\n* VpS or IRSplus algorithm contraindications;\n* Age \\< 18 years;\n* Life expectancy \\< 12 months;\n* Cardiac surgery planned within the FU period;\n* Participation to another clinical investigation;'}, 'identificationModule': {'nctId': 'NCT01528657', 'acronym': 'VIPERS', 'briefTitle': 'Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'orgStudyIdInfo': {'id': 'BA098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventricular Pace Suppression (VpS)', 'description': 'The function Ventricular Pace Suppression (VpS) is activated', 'interventionNames': ['Other: Ventricular Pace Suppression (Vps)']}, {'type': 'EXPERIMENTAL', 'label': 'Intrinsic Rhythm Support (IRSplus)', 'description': 'The function Intrinsic Rhythm Support (IRSplus) is activated', 'interventionNames': ['Other: Intrinsic rhythm support (IRSplus)']}], 'interventions': [{'name': 'Ventricular Pace Suppression (Vps)', 'type': 'OTHER', 'description': 'Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.', 'armGroupLabels': ['Ventricular Pace Suppression (VpS)']}, {'name': 'Intrinsic rhythm support (IRSplus)', 'type': 'OTHER', 'description': "All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.", 'armGroupLabels': ['Intrinsic Rhythm Support (IRSplus)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seriate', 'state': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedale Bolognini', 'geoPoint': {'lat': 45.68532, 'lon': 9.72487}}, {'city': 'Casarano', 'state': 'Lecce', 'country': 'Italy', 'facility': 'P.O. F. Ferrari', 'geoPoint': {'lat': 40.01131, 'lon': 18.16237}}, {'city': 'Pieve di Coriano', 'state': 'Mantova', 'country': 'Italy', 'facility': 'A.O. Destra Secchia', 'geoPoint': {'lat': 45.03388, 'lon': 11.1078}}, {'city': 'Castellammare di Stabia', 'state': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale San Leonardo', 'geoPoint': {'lat': 40.70211, 'lon': 14.48685}}, {'city': 'Borgomanero', 'state': 'Novara', 'country': 'Italy', 'facility': 'Ospedale SS. Trinità', 'geoPoint': {'lat': 45.69873, 'lon': 8.4623}}, {'city': 'Pescia', 'state': 'Pistoia', 'country': 'Italy', 'facility': 'Ospedale SS. Cosma e Damiano', 'geoPoint': {'lat': 43.8871, 'lon': 10.68849}}, {'city': 'Moncalieri', 'state': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Santa Croce', 'geoPoint': {'lat': 44.9994, 'lon': 7.68236}}, {'city': 'Gallarate', 'state': 'Varese', 'country': 'Italy', 'facility': 'Ospedale S.Antonio Abate', 'geoPoint': {'lat': 45.66019, 'lon': 8.79164}}, {'city': 'Mestre', 'state': 'Venezia', 'country': 'Italy', 'facility': "Ospedale Dell'Angelo", 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'A.O.U. Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Biella', 'country': 'Italy', 'facility': 'Ospedale Degli Infermi', 'geoPoint': {'lat': 45.56304, 'lon': 8.05796}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'A.O.U. Policlinico-Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Empoli', 'country': 'Italy', 'facility': 'Ospedale S. Giuseppe', 'geoPoint': {'lat': 43.71795, 'lon': 10.94758}}, {'city': 'Isernia', 'country': 'Italy', 'facility': 'Osp. Civile F. Veneziale', 'geoPoint': {'lat': 41.59603, 'lon': 14.23399}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'P.O. Vito Fazzi', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'A.O.R.N. dei Colli - PO "V. Monaldi"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pordenone', 'country': 'Italy', 'facility': 'A.O. Santa Maria Degli Angeli', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'city': 'Potenza', 'country': 'Italy', 'facility': 'A.O. San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'city': 'Rimini', 'country': 'Italy', 'facility': 'Ospedale Degli Infermi', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Venezia', 'country': 'Italy', 'facility': 'Ospedale SS. Giovanni e Paolo', 'geoPoint': {'lat': 44.42329, 'lon': 11.17365}}], 'overallOfficials': [{'name': 'Alessandro Capucci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Ospedali Riuniti, Ancona'}, {'name': 'Valeria Calvi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Policlinico-Vittorio Emanuele, Catania'}, {'name': 'Marco Brieda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Santa Maria degli Angeli, Pordenone'}, {'name': 'Ennio Pisanò', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P.O. Vito Fazzi, Lecce'}, {'name': 'Vittorio Giudici', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Bolognini, Seriate'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}