Atrial Fibrillation Clinical Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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