NCT00239226

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

April 1, 2012

Enrollment Period

3.1 years

First QC Date

October 13, 2005

Results QC Date

November 6, 2009

Last Update Submit

September 20, 2013

Conditions

Sinus ArrhythmiaAtrial Fibrillation

Keywords

atrial fibrillationinteratrial septumatrial pacingsymptomatic sinus node dysfunction,pacemaker indication class I

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups

    January 2009

  • Number of Patients With Permanent Atrial Fibrillation (AF)

    January 2009

  • Symptom Scale Questionnaire: Comparison Between All Groups

    January 2009

  • Number of Cardioversion: Comparison Between All Groups

    January 2009

  • Heart Failure: Comparison Between All Groups

    January 2009

  • +4 more secondary outcomes

Study Arms (4)

1. IAS pacing - study group

EXPERIMENTAL

Patients were first submitted to electrophysiological study to assess Delta CTos \> or \< 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (1) includes patients with Delta CTos \>50 ms and randomized IAS pacing. IAS Pacing -Study Group: Patients with Delta CTos \>50 ms (study group) at the electrophysiologic study and randomized Interatrial Septum Pacing

Procedure: IAS pacing - study group

2. IAS pacing-control group

EXPERIMENTAL

(Delta CTos\<50ms) Patients were first submitted to electrophysiological study to assess Delta CTos \> or \< 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (2) includes patients with Delta CTos \<50 ms and randomized IAS pacing. IAS Pacing -Control Group: Patients with Delta CTos \<50 ms (control group) at the electrophysiologic study and randomized Interatrial Septum Pacing

Procedure: IAS pacing control group

3. RAA Pacing - study group

ACTIVE COMPARATOR

Patients were first submitted to electrophysiological study to assess Delta CTos \> or \< 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (3) includes patients with Delta CTos \>50 ms and randomized Right Atrial Appendage pacing. RAA Pacing -Study Group: Patients with Delta CTos \>50 ms (study group) at the electrophysiologic study and randomized Right Atrial Appendage pacing

Procedure: Pacing RAA study group

4. RAA Pacing - control group

ACTIVE COMPARATOR

Patients were first submitted to electrophysiological study to assess Delta CTos \> or \< 50 ms. Then they were randomized to interatrial septum pacing od right atrial appendage. This arm (4) includes patients with Delta CTos \<50 ms and randomized Right Atrial Appendage pacing. RAA Pacing -Control Group: Patients with Delta CTos \<50 ms (control group) at the electrophysiologic study and randomized Right Atrial Appendage pacing

Procedure: Pacing RAA control group

Interventions

IAS pacing - study groupPROCEDURE

site of implant and permanent pacing

1. IAS pacing - study group
IAS pacing control groupPROCEDURE

site of implant and permanent pacing

2. IAS pacing-control group
Pacing RAA study groupPROCEDURE

site of implant and permanent pacing

3. RAA Pacing - study group
Pacing RAA control groupPROCEDURE

site of implant and permanent pacing

4. RAA Pacing - control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Azienda Ospedaliera di Desenzano del Garda

Desenzano, BS, Italy

Location

Divisione di Cardiologia

Como, CO, 22100, Italy

Location

Divisione di Cardiologia - CRN

Pisa, PI, 56127, Italy

Location

Divisione di Cardiologia - Ospedale Cisanello

Pisa, PI, 56127, Italy

Location

Divisione di Cardiologia - Ospedale San Pietro Igneo

Fucecchio, Prato, Italy

Location

Divisione di Cardiologia - Ospedale Molinette

Torino, TO, 10126, Italy

Location

Divisione di Cardiologia - Ospedale Civile ULSS 13

Mirano, VE, 30035, Italy

Location

Divisione di Cardiologia - Presidi Ospedalieri Riuniti

Borgomanero, 28100, Italy

Location

Related Publications (26)

  • 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. doi: 10.1016/0002-8703(88)90244-x.

    PMID: 3394616BACKGROUND

  • 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. doi: 10.1111/j.1540-8159.1990.tb06946.x.

    PMID: 1704597BACKGROUND

  • 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. doi: 10.1016/0002-9149(90)91379-k.

    PMID: 2316455BACKGROUND

  • 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. doi: 10.1161/01.cir.88.3.1045.

    PMID: 8353866BACKGROUND

  • 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. doi: 10.1016/S0140-6736(97)03425-9.

    PMID: 9652562BACKGROUND

  • 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. doi: 10.1056/NEJM200005113421902.

    PMID: 10805823BACKGROUND

  • 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. doi: 10.1111/j.1540-8159.1988.tb06289.x.

    PMID: 2463527BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1016/0735-1097(96)00232-x.

    PMID: 8772757BACKGROUND

  • 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. doi: 10.1016/s0735-1097(98)00489-6.

    PMID: 9857870BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1161/01.cir.94.3.384.

    PMID: 8759080BACKGROUND

  • 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. doi: 10.1016/s0002-9149(83)80022-8.

    PMID: 6849250BACKGROUND

  • 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. doi: 10.1023/a:1009867305678.

    PMID: 10354974BACKGROUND

  • 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. doi: 10.1046/j.1540-8167.2003.03191.x.

    PMID: 14678133BACKGROUND

  • 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. doi: 10.1111/j.1540-8167.1999.tb00635.x.

    PMID: 9930903BACKGROUND

  • 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. doi: 10.1111/j.1540-8159.2000.tb06753.x.

    PMID: 10750128BACKGROUND

  • 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. doi: 10.1111/j.1540-8159.2000.tb00783.x.

    PMID: 11202254BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1016/s0735-1097(00)00631-8.

    PMID: 10841247BACKGROUND

  • 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. doi: 10.1046/j.1540-8167.2002.01264.x.

    PMID: 12521344BACKGROUND

  • 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. doi: 10.1046/j.1540-8167.2001.00912.x.

    PMID: 11513442BACKGROUND

  • 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. doi: 10.1046/j.1460-9592.2003.00146.x.

    PMID: 12685136BACKGROUND

  • 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. doi: 10.1111/j.1540-8159.2004.00546.x.

    PMID: 15189515BACKGROUND

  • 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. doi: 10.1046/j.1540-8167.2005.40435.x.

    PMID: 15817085BACKGROUND

  • Verlato R, Botto GL, Massa R, Amellone C, Perucca A, Bongiorni MG, Bertaglia E, Ziacchi V, Piacenti M, Del Rosso A, Russo G, Baccillieri MS, Turrini P, Corbucci G. Efficacy of low interatrial septum and right atrial appendage pacing for prevention of permanent atrial fibrillation in patients with sinus node disease: results from the electrophysiology-guided pacing site selection (EPASS) study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):844-50. doi: 10.1161/CIRCEP.110.957126. Epub 2011 Sep 23.

    PMID: 21946316DERIVED

MeSH Terms

Conditions

Arrhythmia, SinusAtrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Giorgio Corbucci - Sr Principal Scientist
Organization
Medtronic BRC - Medtronic Italia SpA
giovanna.zucchi@medtronic.com
+39 02 241371

Study Officials

  • Giorgio Corbucci, PhD

    Medtronic

    STUDY DIRECTOR

  • Roberto Verlato, MD

    Camposampiero Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 14, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

November 25, 2013

Results First Posted

November 25, 2013

Record last verified: 2012-04

Locations

IT(8)