Electrophysiologically Guided PAcing Site Selection Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigational New Drug Application/ Investigational Device Exemption Information

Conditions
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Sinus Arrhythmia, Atrial Fibrillation

Intervention / Treatment
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* Procedure: IAS pacing - study group
* Procedure: IAS pacing control group
* Procedure: Pacing RAA study group
* Procedure: Pacing RAA control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. IAS pacing - study group<br>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<br>* site of implant and permanent pacing<br>|
| Experimental: 2. IAS pacing-control group<br>(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<br>* site of implant and permanent pacing<br>|
| Active Comparator: 3. RAA Pacing - study group<br>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<br>* site of implant and permanent pacing<br>|
| Active Comparator: 4. RAA Pacing - control group<br>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<br>* site of implant and permanent pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to First Persistent Episode of Atrial Fibrillation (AF) |  | January 2009 | 
| Number of Episodes/Day |  | January 2009 | 
| AF Burden |  | January 2009 | 
| Ventricular Pacing Percentage |  | January 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, interatrial septum, atrial pacing, symptomatic sinus node dysfunction,, pacemaker indication class I