Skip to main content
OpenTrials
Completed

NCT Number: NCT00161538

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helios-Klinikum Aue, Aue, Germany

Loading trial locations.

About this study

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:

  • Free atrial wall
  • right atrial appendage
  • coronary sinus-os
  • Dual site right atrial pacing: b) plus c).

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sick Sinus Syndrome
  • Symptomatic sinus bradycardia
  • Symptomatic SA block
  • Bradycardia-Tachycardia-Syndrom
  • Binodal diseases, Sinus Node Syndrome and high degree AV-Block
  • In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment

Exclusion criteria

  • Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion
  • Decompensated heart failure
  • Dilatative cardiomyopathy with an ejection fraction < 35%
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyreosis
  • Myocardial infarction less than 6 months ago
  • Planned cardiac surgery intervention
  • Pregnant woman
  • Patients under 18 years of age
  • Patients involved in other studies
  • Patients, already implanted with other (cardiac) leads
  • Patients with reduced expectancy of life due to other diseases
  • Patients who are not able to agree in participation of the study
  • Patients, who cannot attend follow-up visits due to their place of residence

Treatment and study plan

Pacing leads to be implanted according randomization.

Device

Selection 9000 prevent AF an Diagnose AF

Device

Primary outcomes

  1. 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.

  2. 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant

Secondary outcomes

  1. Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.

  2. Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants

Sponsors and collaborators

Lead sponsor

Medtronic BRC

Industry

Collaborators

  • Vitatron GmbH

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Oct 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.