Electrophysiologically Guided PAcing Site Selection Study

Phase 4

Completed

Conditions: Sinus Arrhythmia
Atrial Fibrillation

Interventions: Procedure: IAS pacing - study group
Procedure: IAS pacing control group
Procedure: Pacing RAA study group
Procedure: Pacing RAA control group

Registration Number: NCT00239226

Lead Sponsor: Medtronic BRC

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. IAS pacing - study group	IAS pacing - study group	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
2. IAS pacing-control group	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	Pacing RAA study group	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
4. RAA Pacing - control group	Pacing RAA control group	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

Primary Outcome Measures

Name	Time	Method
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	1 year	Persistent Atrial Fibrillation (AF) incidence

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Permanent Atrial Fibrillation (AF)	January 2009
Number of Cardioversion: Comparison Between All Groups	January 2009
Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups	January 2009
Symptom Scale Questionnaire: Comparison Between All Groups	January 2009
Heart Failure: Comparison Between All Groups	January 2009
Number of Episodes/Day	January 2009
AF Burden	January 2009
Time to First Persistent Episode of Atrial Fibrillation (AF)	January 2009
Ventricular Pacing Percentage	January 2009

Trial Locations

Locations (8): Divisione di Cardiologia
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Como, CO, Italy
Azienda Ospedaliera di Desenzano del Garda
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Desenzano, BS, Italy
Divisione di Cardiologia - CRN
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Pisa, PI, Italy
Divisione di Cardiologia - Ospedale San Pietro Igneo
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Fucecchio, Prato, Italy
Divisione di Cardiologia - Ospedale Cisanello
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Pisa, PI, Italy
Divisione di Cardiologia - Ospedale Molinette
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Torino, TO, Italy
Divisione di Cardiologia - Ospedale Civile ULSS 13
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Mirano, VE, Italy
Divisione di Cardiologia - Presidi Ospedalieri Riuniti
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Borgomanero, Italy