Clinical Trial: Electrophysiologically Guided PAcing Site Selection Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Investigational New Drug Application/ Investigational Device Exemption Information

Brief 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 Summary:

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.


Sponsor: Medtronic BRC

Current Primary Outcome: 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 [ Time Frame: 1 year ]

Persistent Atrial Fibrillation (AF) incidence


Original Primary Outcome: Number of patients with persistent AF at 2 year follow-up: comparison between IAS and RAA pacing in the group with severe conduction delay.

Current Secondary Outcome:

  • Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups [ Time Frame: January 2009 ]
  • Number of Patients With Permanent Atrial Fibrillation (AF) [ Time Frame: January 2009 ]
  • Symptom Scale Questionnaire: Comparison Between All Groups [ Time Frame: January 2009 ]
  • Number of Cardioversion: Comparison Between All Groups [ Time Frame: January 2009 ]
  • Heart Failure: Comparison Between All Groups [ Time Frame: January 2009 ]
  • Time to First Persistent Episode of Atrial Fibrillation (AF) [ Time Frame: January 2009 ]
  • Number of Episodes/Day [ Time Frame: January 2009 ]
  • AF Burden [ Time Frame: January 2009 ]
  • Ventricular Pacing Percentage [ Time Frame: January 2009 ]


Original Secondary Outcome:

  • 1. Number of patients with persistent AF at 2 year follow-up: comparison between all groups
  • 2. Number of persistent AF episodes: comparison between all groups
  • 3. Number of patients with permanent AF
  • 4. Symptom scale questionnaire: comparison between all groups
  • 5. Number of cardioversion: comparison between all groups
  • 6. Heart failure: comparison between all groups
  • 7. Time to first persistent episode of AF
  • 8. Number of episodes/day
  • 9. AF burden
  • 10. Time to first paroxysmal episode
  • 11. Ventricular pacing percentage
  • 12. Average sinus rhythm duration


Information By: Medtronic BRC

Dates:
Date Received: October 13, 2005
Date Started: November 2005
Date Completion:
Last Updated: September 20, 2013
Last Verified: April 2012