Electrophysiologically Guided PAcing Site Selection Study - Full Text View

Purpose

This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial appendage (RAA).

Condition	Intervention	Phase
Sinus Arrhythmia Atrial Fibrillation	Procedure: IAS pacing Procedure: RAA pacing	Phase IV

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics:

Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Investigational New Drug Application/ Investigational Device Exemption Information

Further study details as provided by Medtronic - Vitatron:

Primary Outcome Measures:

Number of patients with persistent AF at 2 year follow-up: comparison between IAS and RAA pacing in the group with severe conduction delay

Secondary Outcome Measures:

Number of patients with persistent AF at 2 year follow-up: comparison between all groups
Number of persistent AF episodes: comparison between all groups
Number of patients with permanent AF
Symptom scale questionnaire: comparison between all groups
Number of cardioversion: comparison between all groups
Heart failure: comparison between all groups
Time to first persistent episode of AF
Number of episodes/day
AF burden
Time to first paroxysmal episode
Ventricular pacing percentage
Average sinus rhythm duration

Estimated Enrollment:

300

Detailed Description:

The EPASS is a multicenter, prospective, randomized, and controlled study.

Prior to entering the study, the patient should be informed and provide a written consent. In addition, the patient should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model T70 or Selection 9000 (or later version).

Patients eligible for the study are enrolled and submitted to the evaluation of intra-light atrial conduction delay before device implantation. Besides, they are assigned to the group with severe RA conduction delay or with normal conduction delay. The randomization of the pacing site for both groups depends on the value of right atrial conduction delay, together with the associated diseases of the patients, sex and age. After implantation, a stabilization phase of 3-5 weeks is required to stabilize the leads: during this period the physician can optimize the device parameters. Neither the data regarding AF episodes nor cardioversion are collected.

At the end of the stabilization phase the patient undergoes the 1st study follow-up and starts the monitoring period lasting 2 years. Regular follow-ups and data collection are scheduled every 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptomatic sinus node dysfunction
More than 18 years old
Signed informed consent

Exclusion Criteria:

Less than 18 years old
Pregnancy
Anamnestic transient ischemic attack (TIA) or stroke
Neoplastic or any other severe disease reducing life expectancy
Heart surgery in the last 3 months
Left atrial diameter > 55mm, determined in the parasternal long-axis view (during either sinus rhythm or atrial fibrillation)
Participation in other studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239226

Contacts


Contact: Giovanna Zucchi	+39 051 4188724	giovanna.zucchi@vitatron.com

Contact: Giorgio Corbucci, PhD	+39 051 4188711	giorgio.corbucci@vitatron.com

Locations


Italy, BS
	Divisione di Cardiologia - Ospedale Civile	Not yet recruiting
	Desenzano, BS, Italy, 25015
	Contact: Adriana Righettini +39 030 9145492 Adriana.righettini@aod.it
	Principal Investigator: Vigilio Ziacchi, MD

Italy, CO
	Divisione di Cardiologia	Not yet recruiting
	Como, CO, Italy, 22100
	Contact: Luisa Clerici +39 031 5855620 comitato.etica@hsacomo.it
	Principal Investigator: Gianluca Botto, MD

Italy, LI
	Divisione di Cardiologia - Ospedale civile	Not yet recruiting
	Livorno, LI, Italy, 57100
	Contact: Fabio Lena +39 0586 223738
	Principal Investigator: Luca Paperini, MD

Italy, MI
	Divisione di Cardiologia - Ospedale S. Gerardo	Not yet recruiting
	Monza, MI, Italy, 20052
	Contact: Melchiorre +39 039 2333693 comitato.etico@hsgerardo.org
	Principal Investigator: Antonio Vincenti, MD
	Divisione di Cardiologia - Ospedale Sacco	Not yet recruiting
	Milano, MI, Italy, 20157
	Contact: Nicoletta Buonfiglio +39 02 39043518 comitato.etico@hsacco.it
	Principal Investigator: Francesco Lopresti, MD

Italy, NO
	Divisione di Cardiologia - Presidi Ospedalieri Riuniti	Not yet recruiting
	Borgomanero, NO, Italy, 28100
	Contact: A. Fornara +39 0322 848307
	Principal Investigator: Antonella Perucca, MD

Italy, PD
	Divisione di Cardiologia - Ospedale P. Cosma	Not yet recruiting
	Camposampiero, PD, Italy, 35012
	Contact: Roberta Rampazzo +39 0499324791 comitato_etico@ulss15.pd.it
	Principal Investigator: Roberto Verlato, MD

Italy, PI
	Divisione di Cardiologia - Ospedale Cisanello	Not yet recruiting
	Pisa, PI, Italy, 56127
	Contact: Franca Cossu +39 050 996255 f.cossu@ao-pisa.toscana.it
	Principal Investigator: Maria Grazia Bongiorni, MD
	Divisione di Cardiologia - CRN	Not yet recruiting
	Pisa, PI, Italy, 56127
	Contact: Franca Cossu +39 050 996255 f.cossu@ao-pisa.toscana.it
	Principal Investigator: Marcello Piacenti, MD
	Divisione di Cardiologia - Ospedale civile	Not yet recruiting
	Pontedera, PI, Italy, 56125
	Contact: C. Georgi +39 050 954251 c.giorgi@usl5.toscana.it
	Principal Investigator: Stefano Viani, MD

Italy, PU
	Divisione di Cardiologia - Ospedale di Fano	Not yet recruiting
	Fano, PU, Italy, 61032
	Contact: Patrizia Gerboni +39 0721 882700 patrizia.gerboni@asl3.marche.it
	Principal Investigator: Andrea Pozzolini, MD

Italy, RI
	Divisione di Cardiologia - Ospedale Civile	Not yet recruiting
	Rieti, RI, Italy, 2100
	Contact: R. Patoro +39 0746 278662 r.patoro@asl.rieti.it
	Principal Investigator: Serafino Orazi, MD

Italy, RO
	Divisione di Cardiologia - ULSS 18	Not yet recruiting
	Rovigo, RO, Italy, 35100
	Contact: Raffaella Ruzza +39 0425 393208 ruzza.raffaella@azisanrovigo.it
	Principal Investigator: Francesco Zanon, MD

Italy, TA
	Divisione di Cardiologia - Ospedale SS Annunziata	Not yet recruiting
	Taranto, TA, Italy, 74100
	Contact: G. Cannarile +39 099 4585854 dirmedssannunziata@virgilio.it
	Principal Investigator: Vitantonio Russo, MD

Italy, to
	Divisione di Cardiologia - Ospedale Molinette	Not yet recruiting
	Torino, to, Italy, 10126
	Contact: Riccardo Massa, MD +39 011 6336547
	Principal Investigator: Riccardo Massa, MD
	Divisione di Cardiologia - USL 7	Not yet recruiting
	Chivasso, to, Italy, 10034
	Contact: Lorella Serra +39 011 9176273
	Principal Investigator: Antonio Mazza, MD

Italy, TV
	Divisione di Cardiologia - Presidio ospedaliero di Treviso	Not yet recruiting
	Treviso, TV, Italy, 31100
	Contact: Annamaria Ciaglia +39 0422 322477 segcomitatoeticotv@ulss.tv.it
	Principal Investigator: Roberto Mantovan, MD

Italy, VE
	Divisione di Cardiologia - Azienda ospedaliera di Verona	Not yet recruiting
	Verona, VE, Italy, 37122
	Contact: Comitato Etico +39 045 8074068 comitato.etico@mail.azosp.vr.it
	Principal Investigator: Zanotto, MD
	Divisione di Cardiologia	Not yet recruiting
	Portogruaro, VE, Italy, 30027
	Contact +39 0421 764254 dirmed.portogruaro@aulls10.veneto.it
	Principal Investigator: Roberto Cazzin, MD
	Divisione di Cardiologia - Ospedale Civile ULSS 13	Not yet recruiting
	Mirano, VE, Italy, 30035
	Contact: Mazzucco +39 041 5794433 comitatoetico.mirano@ulss13mirano.ven.it
	Principal Investigator: Emanuele Bertaglia, MD

Sponsors and Collaborators

Medtronic - Vitatron

Vitatron Medical Italia

Investigators


Study Director:	Giorgio Corbucci, PhD	Vitatron Medical Italia

Principal Investigator:	Roberto Verlato, MD	Camposampiero Hospital

More Information

Publications:

Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22.

Stangl K, Seitz K, Wirtzfeld A, Alt E, Blomer H. Differences between atrial single chamber pacing (AAI) and ventricular single chamber pacing (VVI) with respect to prognosis and antiarrhythmic effect in patients with sick sinus syndrome. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2080-5.

Santini M, Alexidou G, Ansalone G, Cacciatore G, Cini R, Turitto G. Relation of prognosis in sick sinus syndrome to age, conduction defects and modes of permanent cardiac pacing. Am J Cardiol. 1990 Mar 15;65(11):729-35.

Sgarbossa EB, Pinski SL, Maloney JD, Simmons TW, Wilkoff BL, Castle LW, Trohman RG. Chronic atrial fibrillation and stroke in paced patients with sick sinus syndrome. Relevance of clinical characteristics and pacing modalities. Circulation. 1993 Sep;88(3):1045-53.

Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.

Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91.

Attuel P, Pellerin D, Mugica J, Coumel P. DDD pacing: an effective treatment modality for recurrent atrial arrhythmias. Pacing Clin Electrophysiol. 1988 Nov;11(11 Pt 2):1647-54.

8. Daubert C, Mabo B, Berder V. Arrhythmia prevention by permanent atrial resynchronization in advanced interatrial block. Eur Heart J 1990;11: 237-42.

Saksena S, Prakash A, Hill M, Krol RB, Munsif AN, Mathew PP, Mehra R. Prevention of recurrent atrial fibrillation with chronic dual-site right atrial pacing. J Am Coll Cardiol. 1996 Sep;28(3):687-94.

Delfaut P, Saksena S, Prakash A, Krol RB. Long-term outcome of patients with drug-refractory atrial flutter and fibrillation after single- and dual-site right atrial pacing for arrhythmia prevention. J Am Coll Cardiol. 1998 Dec;32(7):1900-8.

11. Prakash A, Giorgberidze I. Endocardial mapping of sites of conduction delay for atrial premature beats in patients with atrial fibrillation. PACE 1997;20 (part II):1161.

Papageorgiou P, Monahan K, Boyle NG, Seifert MJ, Beswick P, Zebede J, Epstein LM, Josephson ME. Site-dependent intra-atrial conduction delay. Relationship to initiation of atrial fibrillation. Circulation. 1996 Aug 1;94(3):384-9.

Cosio FG, Palacios J, Vidal JM, Cocina EG, Gomez-Sanchez MA, Tamargo L. Electrophysiologic studies in atrial fibrillation. Slow conduction of premature impulses: a possible manifestation of the background for reentry. Am J Cardiol. 1983 Jan 1;51(1):122-30.

Padeletti L, Porciani MC, Michelucci A, Colella A, Ticci P, Vena S, Costoli A, Ciapetti C, Pieragnoli P, Gensini GF. Interatrial septum pacing: a new approach to prevent recurrent atrial fibrillation. J Interv Card Electrophysiol. 1999 Mar;3(1):35-43.

Padeletti L, Purerfellner H, Adler SW, Waller TJ, Harvey M, Horvitz L, Holbrook R, Kempen K, Mugglin A, Hettrick DA; Worldwide ASPECT Investigators. Combined efficacy of atrial septal lead placement and atrial pacing algorithms for prevention of paroxysmal atrial tachyarrhythmia. J Cardiovasc Electrophysiol. 2003 Nov;14(11):1189-95.

Stabile G, Senatore G, De Simone A, Turco P, Coltorti F, Nocerino P, Vitale DF, Chiariello M. Determinants of efficacy of atrial pacing in preventing atrial fibrillation recurrences. J Cardiovasc Electrophysiol. 1999 Jan;10(1):2-9.

De Sisti A, Attuel P, Manot S, Fiorello P, Halimi F, Leclercq JF. Electrophysiological characteristics of the atrium in sinus node dysfunction with and without postpacing atrial fibrillation. Pacing Clin Electrophysiol. 2000 Mar;23(3):303-8.

Leclercq JF, De Sisti A, Fiorello P, Halimi F, Manot S, Attuel P. Is dual site better than single site atrial pacing in the prevention of atrial fibrillation? Pacing Clin Electrophysiol. 2000 Dec;23(12):2101-7.

19. Attuel P, Pellerin D, Gaston J et al: Latent atrial vulnerability: new means of electrophysiologic investigation in atrial arrhythmias. In Attuel P, Coumel P, Janse M,eds:The Atrium in Health and Disease.Futura Publishing Co.,Inc.,Mt.Kisco,NY,1989,pp159-200.

Becker R, Klinkott R, Bauer A, Senges JC, Schreiner KD, Voss F, Kuebler W, Schoels W. Multisite pacing for prevention of atrial tachyarrhythmias: potential mechanisms. J Am Coll Cardiol. 2000 Jun;35(7):1939-46.

Duytschaever M, Danse P, Eysbouts S, Allessie M. Is there an optimal pacing site to prevent atrial fibrillation?: an experimental study in the chronically instrumented goat. J Cardiovasc Electrophysiol. 2002 Dec;13(12):1264-71.

Bailin SJ, Adler S, Giudici M. Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. J Cardiovasc Electrophysiol. 2001 Aug;12(8):912-7.

Hermida JS, Carpentier C, Kubala M, Otmani A, Delonca J, Jarry G, Rey JL. Atrial septal versus atrial appendage pacing: feasibility and effects on atrial conduction, interatrial synchronization, and atrioventricular sequence. Pacing Clin Electrophysiol. 2003 Jan;26(1 Pt 1):26-35.

Padeletti L, Michelucci A, Pieragnoli P, Colella A, Musilli N. Atrial septal pacing: a new approach to prevent atrial fibrillation. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):850-4. Review.

Duytschaever M, Firsovaite V, Colpaert R, Allessie M, Tavernier R. Limited benefit of septal pre-excitation in pace prevention of atrial fibrillation. J Cardiovasc Electrophysiol. 2005 Mar;16(3):269-77.

Study ID Numbers:	EPASS
First Received:	October 13, 2005
Last Updated:	October 24, 2006
ClinicalTrials.gov Identifier:	NCT00239226
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Medtronic - Vitatron:

atrial fibrillation

interatrial septum

atrial pacing

symptomatic sinus node dysfunction,

pacemaker indication class I

Study placed in the following topic categories:

Heart Diseases

Arrhythmia, Sinus

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Medtronic - Vitatron Vitatron Medical Italia
Information provided by:	Medtronic - Vitatron
ClinicalTrials.gov Identifier:	NCT00239226