Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

NCT01528657 | Completed

• 1 other identifier: BA098
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Sick Sinus Syndrome

Keywords

Sick Sinus Syndrome; Ventricular pacing; Minimal ventricular pacing; Ventricular pacing suppression; Intrinsic rhythm support; Long term AV

Outcome Measures

Primary Outcomes (1)

• Ventricular pacing percentage

  6 months

Secondary Outcomes (3)

• Long-term atrio-ventricular conduction delay

  6 Months

• Occurrence of atrial tachycardia or atrial fibrillation events

  6 Months

• Burden of atrial fibrillation

  6 Months

Study Arms (2)

Ventricular Pace Suppression (VpS)

EXPERIMENTAL

The function Ventricular Pace Suppression (VpS) is activated

Other: Ventricular Pace Suppression (Vps)

Intrinsic Rhythm Support (IRSplus)

EXPERIMENTAL

The function Intrinsic Rhythm Support (IRSplus) is activated

Other: Intrinsic rhythm support (IRSplus)

Interventions

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.

Ventricular Pace Suppression (VpS)

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.

Intrinsic Rhythm Support (IRSplus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age;
• 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;

You may not qualify if:

• Permanent or paroxysmal AV block ≥ II;
• 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;

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (20)

Ospedale Bolognini

Seriate, Bergamo, Italy

Location

P.O. F. Ferrari

Casarano, Lecce, Italy

Location

A.O. Destra Secchia

Pieve di Coriano, Mantova, Italy

Location

Ospedale San Leonardo

Castellammare di Stabia, Napoli, Italy

Location

Ospedale SS. Trinità

Borgomanero, Novara, Italy

Location

Ospedale SS. Cosma e Damiano

Pescia, Pistoia, Italy

Location

Ospedale Santa Croce

Moncalieri, Torino, Italy

Location

Ospedale S.Antonio Abate

Gallarate, Varese, Italy

Location

Ospedale Dell'Angelo

Mestre, Venezia, Italy

Location

A.O.U. Ospedali Riuniti di Ancona

Ancona, Italy

Location

Ospedale Degli Infermi

Biella, Italy

Location

A.O.U. Policlinico-Vittorio Emanuele

Catania, Italy

Location

Ospedale S. Giuseppe

Empoli, Italy

Location

Osp. Civile F. Veneziale

Isernia, Italy

Location

P.O. Vito Fazzi

Lecce, Italy

Location

A.O.R.N. dei Colli - PO "V. Monaldi"

Napoli, Italy

Location

A.O. Santa Maria Degli Angeli

Pordenone, Italy

Location

A.O. San Carlo

Potenza, Italy

Location

Ospedale Degli Infermi

Rimini, Italy

Location

Ospedale SS. Giovanni e Paolo

Venezia, Italy

Location

Related Publications (12)

• 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: 3711479 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.

  PMID: 11991375 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.

  PMID: 2386214 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.

  PMID: 15583083 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.

  PMID: 15489094 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.

  PMID: 6707363 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.

  PMID: 9358483 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.

  PMID: 12932590 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.

  PMID: 9529267 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.

  PMID: 15519023 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.

  PMID: 12782566 BACKGROUND

• 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.

  PMID: 29759604 DERIVED

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 8, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

IT (20)