Electrophysiologically Guided PAcing Site Selection Study (EPASS)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Sinus Arrhythmia

Treatments: Procedure: Pacing RAA study group; Procedure: IAS pacing - study group; Procedure: Pacing RAA control group; Procedure: IAS pacing control group

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239226

EPASS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 4 patient groups

1. IAS pacing - study group

Experimental group

Description:

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

Treatment:

Procedure: IAS pacing - study group

2. IAS pacing-control group

Experimental group

Description:

(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

Treatment:

Procedure: IAS pacing control group

3. RAA Pacing - study group

Active Comparator group

Description:

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

Treatment:

Procedure: Pacing RAA study group

4. RAA Pacing - control group

Active Comparator group

Description:

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

Treatment:

Procedure: Pacing RAA control group