Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Sick Sinus Syndrome Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528657
• Other study ID #: BA098
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: October 21, 2015
• Start date: December 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sick Sinus Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	A.O.U. Ospedali Riuniti di Ancona	Ancona
Italy	Ospedale Degli Infermi	Biella
Italy	Ospedale SS. Trinità	Borgomanero	Novara
Italy	P.O. F. Ferrari	Casarano	Lecce
Italy	Ospedale San Leonardo	Castellammare	Napoli
Italy	A.O.U. Policlinico-Vittorio Emanuele	Catania
Italy	Ospedale S. Giuseppe	Empoli
Italy	Ospedale S.Antonio Abate	Gallarate	Varese
Italy	Osp. Civile F. Veneziale	Isernia
Italy	P.O. Vito Fazzi	Lecce
Italy	Ospedale Dell'Angelo	Mestre	Venezia
Italy	Ospedale Santa Croce	Moncalieri	Torino
Italy	A.O.R.N. dei Colli - PO "V. Monaldi"	Napoli
Italy	Ospedale SS. Cosma e Damiano	Pescia	Pistoia
Italy	A.O. Destra Secchia	Pieve di Coriano	Mantova
Italy	A.O. Santa Maria Degli Angeli	Pordenone
Italy	A.O. San Carlo	Potenza
Italy	Ospedale Degli Infermi	Rimini
Italy	Ospedale Bolognini	Seriate	Bergamo
Italy	Ospedale SS. Giovanni e Paolo	Venezia

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2003 Jun 2. — View Citation

Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jaïs P, Haïssaguerre 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. Epub 2004 Dec 6. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular pacing percentage		6 months	No
Secondary	Long-term atrio-ventricular conduction delay		6 Months	No
Secondary	Occurrence of atrial tachycardia or atrial fibrillation events		6 Months	No
Secondary	Burden of atrial fibrillation		6 Months	No