NCT00239226

Electrophysiologically Guided PAcing Site Selection Study

Investigational New Drug Application/ Investigational Device Exemption Information

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinus Arrhythmia
• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	IAS pacing - study group	site of implant and permanent pacing
PROCEDURE	IAS pacing control group	site of implant and permanent pacing
PROCEDURE	Pacing RAA study group	site of implant and permanent pacing
PROCEDURE	Pacing RAA control group	site of implant and permanent pacing

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2005-10-14
• Last updated: 2013-11-25
• Results posted: 2013-11-25

Locations

8 sites across 1 country: Italy