Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
NCT ID: NCT01528657
Last Updated: 2015-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2011-12-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Ventricular Pace Suppression (VpS)
The function Ventricular Pace Suppression (VpS) is activated
Ventricular Pace Suppression (Vps)
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.
Intrinsic Rhythm Support (IRSplus)
The function Intrinsic Rhythm Support (IRSplus) is activated
Intrinsic rhythm support (IRSplus)
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.
Interventions
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Ventricular Pace Suppression (Vps)
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.
Intrinsic rhythm support (IRSplus)
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.
Eligibility Criteria
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Inclusion Criteria
* Patient has proven informed consent;
* Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
* 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;
* Stable medical situation;
* Stable geographical situation;
Exclusion Criteria
* Permanent Atrial fibrillation/Atrial flutter;
* Device Replacement;
* Patient with a poor echocardiographic window;
* Patient already implanted with the right ventricular lead not in the apical position;
* Subjects with a dual chamber pacemaker, implanted later than six months;
* Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
* Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
* VpS or IRSplus algorithm contraindications;
* Age \< 18 years;
* Life expectancy \< 12 months;
* Cardiac surgery planned within the FU period;
* Participation to another clinical investigation;
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Alessandro Capucci
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Ospedali Riuniti, Ancona
Valeria Calvi
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Policlinico-Vittorio Emanuele, Catania
Marco Brieda
Role: PRINCIPAL_INVESTIGATOR
A.O. Santa Maria degli Angeli, Pordenone
Ennio Pisanò
Role: PRINCIPAL_INVESTIGATOR
P.O. Vito Fazzi, Lecce
Vittorio Giudici
Role: PRINCIPAL_INVESTIGATOR
Ospedale Bolognini, Seriate
Locations
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Ospedale Bolognini
Seriate, Bergamo, Italy
P.O. F. Ferrari
Casarano, Lecce, Italy
A.O. Destra Secchia
Pieve di Coriano, Mantova, Italy
Ospedale San Leonardo
Castellammare di Stabia, Napoli, Italy
Ospedale SS. Trinità
Borgomanero, Novara, Italy
Ospedale SS. Cosma e Damiano
Pescia, Pistoia, Italy
Ospedale Santa Croce
Moncalieri, Torino, Italy
Ospedale S.Antonio Abate
Gallarate, Varese, Italy
Ospedale Dell'Angelo
Mestre, Venezia, Italy
A.O.U. Ospedali Riuniti di Ancona
Ancona, , Italy
Ospedale Degli Infermi
Biella, , Italy
A.O.U. Policlinico-Vittorio Emanuele
Catania, , Italy
Ospedale S. Giuseppe
Empoli, , Italy
Osp. Civile F. Veneziale
Isernia, , Italy
P.O. Vito Fazzi
Lecce, , Italy
A.O.R.N. dei Colli - PO "V. Monaldi"
Napoli, , Italy
A.O. Santa Maria Degli Angeli
Pordenone, , Italy
A.O. San Carlo
Potenza, , Italy
Ospedale Degli Infermi
Rimini, , Italy
Ospedale SS. Giovanni e Paolo
Venezia, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BA098
Identifier Type: -
Identifier Source: org_study_id
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