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

This study has been completed.
Sponsor:
Collaborator:
Vitatron GmbH
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00161538
First received: September 9, 2005
Last updated: October 19, 2006
Last verified: October 2006

September 9, 2005
October 19, 2006
July 2000
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00161538 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Sick Sinus Syndrome
  • Device: Pacing leads to be implanted according randomization.
  • Device: Selection 9000 prevent AF an Diagnose AF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
456
June 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00161538
PASTA V.1.5
Not Provided
Not Provided
Medtronic BRC
Vitatron GmbH
Principal Investigator: Stefan G. Spitzer, MD
Medtronic BRC
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP