Sinus ArrhythmiaPhase 4EPASSNCT00239226
Electrophysiologically Guided PAcing Site Selection Study
A Phase 4 study testing IAS pacing - study group and Pacing RAA study group in people with Sinus Arrhythmia and Atrial Fibrillation, run by Medtronic BRC at 8 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Arrhythmia, Atrial Fibrillation
- What is being tested?
- IAS pacing - study group and Pacing RAA study group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesItaly
- Study dates
- Nov 2005to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic sinus node dysfunction
- More than 18 years old
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Divisione di Cardiologia - Presidi Ospedalieri Riuniti
Borgomanero, 28100
Divisione di Cardiologia
Como, CO, 22100
Azienda Ospedaliera di Desenzano del Garda
Desenzano, BS
Divisione di Cardiologia - Ospedale San Pietro Igneo
Fucecchio, Prato
Divisione di Cardiologia - Ospedale Civile ULSS 13
Mirano, VE, 30035
Divisione di Cardiologia - CRN
Pisa, PI, 56127
Divisione di Cardiologia - Ospedale Cisanello
Pisa, PI, 56127
Divisione di Cardiologia - Ospedale Molinette
Torino, TO, 10126
About this study
Official title: Investigational New Drug Application/ Investigational Device Exemption Information
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).
Read the 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.
- Conditions
- Sinus Arrhythmia, Atrial Fibrillation
- Being tested
- IAS pacing - study group, IAS pacing control group, Pacing RAA study group, Pacing RAA control group
- Keywords
- atrial fibrillation, interatrial septum, atrial pacing, symptomatic sinus node dysfunction,, pacemaker indication class I
- Medical subject headings
- Arrhythmia, Sinus, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAS pacing - study groupProcedure or surgery
site of implant and permanent pacing
IAS pacing control groupProcedure or surgery
site of implant and permanent pacing
Pacing RAA study groupProcedure or surgery
site of implant and permanent pacing
Pacing RAA control groupProcedure or surgery
site of implant and permanent pacing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Pacing RAA control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (9)
Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups
Measured: January 2009
Number of Patients With Permanent Atrial Fibrillation (AF)
Measured: January 2009
Symptom Scale Questionnaire: Comparison Between All Groups
Measured: January 2009
Number of Cardioversion: Comparison Between All Groups
Measured: January 2009
Heart Failure: Comparison Between All Groups
Measured: January 2009
Time to First Persistent Episode of Atrial Fibrillation (AF)
Measured: January 2009
Number of Episodes/Day
Measured: January 2009
AF Burden
Measured: January 2009
Ventricular Pacing Percentage
Measured: January 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Sinus ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Giorgio Corbucci, PhD, Study director, MedtronicRoberto Verlato, MD, Principal investigator, Camposampiero Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239226
- Sponsor's protocol ID
- EPASS
- Acronym
- EPASS
- Status last verified
- Apr 2012
- First submitted
- 13 Oct 2005
- Last updated
- 25 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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. doi: 10.1016/0002-8703(88)90244-x.
PubMed 3394616Stangl 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.
PubMed 1704597Santini 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.
PubMed 2316455Sgarbossa 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.
PubMed 8353866Andersen 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.
PubMed 9652562Connolly 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.
PubMed 10805823Attuel 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.
PubMed 24635278. 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. doi: 10.1016/0735-1097(96)00232-x.
PubMed 8772757Delfaut 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.
PubMed 985787011. 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. doi: 10.1161/01.cir.94.3.384.
PubMed 8759080Cosio 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.
PubMed 6849250Padeletti 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.
PubMed 10354974Padeletti 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.
PubMed 14678133
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational New Drug Application/ Investigational Device Exemption Information
- ClinicalTrials.gov ID
- NCT00239226
- Acronym / sponsor ID
- EPASS / EPASS
- Conditions
- Sinus Arrhythmia, Atrial Fibrillation
- Keywords
- atrial fibrillation, interatrial septum, atrial pacing, symptomatic sinus node dysfunction,, pacemaker indication class I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Oct 2005 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. IAS pacing - study group | Experimental | Procedure: IAS pacing - study groupPatients 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 |
| 2. IAS pacing-control group | Experimental | Procedure: IAS pacing control group(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 |
| 3. RAA Pacing - study group | Active comparator | Procedure: Pacing RAA study groupPatients 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 |
| 4. RAA Pacing - control group | Active comparator | Procedure: Pacing RAA control groupPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic sinus node dysfunction
- More than 18 years old
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IAS pacing - study groupsite of implant and permanent pacing | Procedure or surgery | 1. IAS pacing - study group |
| IAS pacing control groupsite of implant and permanent pacing | Procedure or surgery | 2. IAS pacing-control group |
| Pacing RAA study groupsite of implant and permanent pacing | Procedure or surgery | 3. RAA Pacing - study group |
| Pacing RAA control groupsite of implant and permanent pacing | Procedure or surgery | 4. RAA Pacing - control group |
Primary outcome
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
Time frame: 1 year
Persistent Atrial Fibrillation (AF) incidence
9 secondary outcomes
Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups
Time frame: January 2009
Number of Patients With Permanent Atrial Fibrillation (AF)
Time frame: January 2009
Symptom Scale Questionnaire: Comparison Between All Groups
Time frame: January 2009
Number of Cardioversion: Comparison Between All Groups
Time frame: January 2009
Heart Failure: Comparison Between All Groups
Time frame: January 2009
Time to First Persistent Episode of Atrial Fibrillation (AF)
Time frame: January 2009
Number of Episodes/Day
Time frame: January 2009
AF Burden
Time frame: January 2009
Ventricular Pacing Percentage
Time frame: January 2009
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3394616Rosenqvist 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.
- Background: PubMed 1704597Stangl 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.
- Background: PubMed 2316455Santini 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.
- Background: PubMed 8353866Sgarbossa 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.
- Background: PubMed 9652562Andersen 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.
- Background: PubMed 10805823Connolly 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.
- Background: PubMed 2463527Attuel 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.
- Background8. Daubert C, Mabo B, Berder V. Arrhythmia prevention by permanent atrial resynchronization in advanced interatrial block. Eur Heart J 1990;11: 237-42.
- Background: PubMed 8772757Saksena 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.
- Background: PubMed 9857870Delfaut 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.
- Background11. 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: PubMed 8759080Papageorgiou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Corbucci, PhD study director
Medtronic
Roberto Verlato, MD principal investigator
Camposampiero Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IAS pacing - study group and Pacing RAA study group in people with Sinus Arrhythmia and Atrial Fibrillation, run by Medtronic BRC at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00239226, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.