NCT00161538

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 456 (planned)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Sick Sinus Syndrome

Interventions

Type	Name	Description
DEVICE	Pacing leads to be implanted according randomization.
DEVICE	Selection 9000 prevent AF an Diagnose AF

Timeline

• Start date: 2000-07-01
• Completion: 2006-06-01
• First posted: 2005-09-12
• Last updated: 2006-10-20

Locations

12 sites across 1 country: Germany