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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventricular Pace Suppression (VpS) | Experimental | The function Ventricular Pace Suppression (VpS) is activated |
|
| Intrinsic Rhythm Support (IRSplus) | Experimental | The function Intrinsic Rhythm Support (IRSplus) is activated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventricular Pace Suppression (Vps) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular pacing percentage | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term atrio-ventricular conduction delay | 6 Months | |
| Occurrence of atrial tachycardia or atrial fibrillation events | 6 Months | |
| Burden of atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Capucci | A.O.U. Ospedali Riuniti, Ancona | Principal Investigator |
| Valeria Calvi | A.O.U. Policlinico-Vittorio Emanuele, Catania | Principal Investigator |
| Marco Brieda | A.O. Santa Maria degli Angeli, Pordenone | Principal Investigator |
| Ennio Pisanò | P.O. Vito Fazzi, Lecce | Principal Investigator |
| Vittorio Giudici | Ospedale Bolognini, Seriate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Bolognini | Seriate | Bergamo | Italy | |||
| P.O. F. Ferrari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3711479 | Background | 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. | |
| 11991375 | Background | 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. |
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| Intrinsic rhythm support (IRSplus) | Other | 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. |
|
| 6 Months |
| 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" | Naples | 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 |
| 2386214 | Background | 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. |
| 15583083 | Background | 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. |
| 15489094 | Background | 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. |
| 6707363 | Background | 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. |
| 9358483 | Background | 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. |
| 12932590 | Background | 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. |
| 9529267 | Background | 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. |
| 15519023 | Background | 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. |
| 12782566 | Background | 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. |
| 29759604 | Derived | 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. |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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