Electrophysiologically Guided PAcing Site Selection Study

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.

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