Electrophysiologically Guided PAcing Site Selection Study

Atrial Fibrillation Clinical Trial

— EPASS  

Official title:

Investigational New Drug Application/ Investigational Device Exemption Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239226
• Other study ID #: EPASS
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: September 20, 2013
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: April 2012
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia, Sinus
• Atrial Fibrillation
• Sinus Arrhythmia

Intervention

Procedure:
• IAS pacing - study group
site of implant and permanent pacing
• IAS pacing control group
site of implant and permanent pacing
• Pacing RAA study group
site of implant and permanent pacing
• Pacing RAA control group
site of implant and permanent pacing

Locations

Country	Name	City	State
Italy	Divisione di Cardiologia - Presidi Ospedalieri Riuniti	Borgomanero
Italy	Divisione di Cardiologia	Como	CO
Italy	Azienda Ospedaliera di Desenzano del Garda	Desenzano	BS
Italy	Divisione di Cardiologia - Ospedale San Pietro Igneo	Fucecchio	Prato
Italy	Divisione di Cardiologia - Ospedale Civile ULSS 13	Mirano	VE
Italy	Divisione di Cardiologia - CRN	Pisa	PI
Italy	Divisione di Cardiologia - Ospedale Cisanello	Pisa	PI
Italy	Divisione di Cardiologia - Ospedale Molinette	Torino	TO

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic BRC	Medtronic

Country where clinical trial is conducted

Italy, 

References & Publications (25)

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.

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cosio FG, Palacios J, Vidal JM, Cocina EG, Gómez-Sánchez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Padeletti L, Pürerfellner 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. — View Citation

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. — View Citation

Rosenqvist M, Brandt J, Schüller 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stangl K, Seitz K, Wirtzfeld A, Alt E, Blömer 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group	Persistent Atrial Fibrillation (AF) incidence	1 year	No
Secondary	Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups		January 2009	No
Secondary	Number of Patients With Permanent Atrial Fibrillation (AF)		January 2009	No
Secondary	Symptom Scale Questionnaire: Comparison Between All Groups		January 2009	No
Secondary	Number of Cardioversion: Comparison Between All Groups		January 2009	No
Secondary	Heart Failure: Comparison Between All Groups		January 2009	No
Secondary	Time to First Persistent Episode of Atrial Fibrillation (AF)		January 2009	No
Secondary	Number of Episodes/Day		January 2009	No
Secondary	AF Burden		January 2009	No
Secondary	Ventricular Pacing Percentage		January 2009	No