Clinical Trial: Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation

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

Official Title: A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome

Brief Summary: The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.

Detailed Summary:

The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF. In this study the incidence of AF will be compared between 4 different atrial lead positions:

  1. Free atrial wall
  2. right atrial appendage
  3. coronary sinus-os
  4. Dual site right atrial pacing: b) plus c).

The following primary parameters will be evaluated during the study period of 2 years after implantation:

  1. Amounts of AF episodes with a duration of > 48 hours
  2. Amounts of AF episodes with a duration of > 30 minutes
  3. Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.

Sponsor: Medtronic BRC

Current Primary Outcome:

  • The incidence of AF is determined via memory of the pacemaker, which is saved at every follow-up visit at 1 and 10 days after implant and further on at 3, 6, 12, 18 and 24 months after implant.
  • 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.
  • Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants


Original Secondary Outcome: Same as current

Information By: Medtronic BRC

Dates:
Date Received: September 9, 2005
Date Started: July 2000
Date Completion: June 2006
Last Updated: October 19, 2006
Last Verified: October 2006