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
  Purpose

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.


Condition Intervention Phase
Sick Sinus Syndrome
Device: Pacing leads to be implanted according randomization.
Device: Selection 9000 prevent AF an Diagnose AF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 456
Study Start Date: July 2000
Estimated Study Completion Date: June 2006
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161538

Locations
Germany
Helios-Klinikum Aue
Aue, Germany, 08280
Klinikum Coburg
Coburg, Germany, 96450
Ambulantes Herz-Zentrum Dresden
Dresden, Germany, 01099
Werner-Forssmann-Krankenhaus GmbH
Eberswalde, Germany, 16225
Klinikum der Joh.-Wolfgang-Goethe-Universität
Frankfurt, Germany, 60596
Städtisches Krankenhaus Friedrichshafen
Friedrichshafen, Germany, 88048
Universitätskrankenhaus Eppendorf
Hamburg, Germany, 20251
Evang. Krankenhaus
Holzminden, Germany, 37603
Klinikum Ingolstadt
Ingolstadt, Germany, 85049
Evangelisches Krankenhaus Kalk GmbH
Köhl, Germany, 51103
Kreiskrankenhaus Leer
Leer, Germany, 26789
Krankenhaus Maria Hilf
Mönchengladbach, Germany, 41063
Sponsors and Collaborators
Medtronic BRC
Vitatron GmbH
Investigators
Principal Investigator: Stefan G. Spitzer, MD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00161538     History of Changes
Other Study ID Numbers: PASTA V.1.5
Study First Received: September 9, 2005
Last Updated: October 19, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:
Cardiac Pacing, artificial
Atrial fibrillation
Pacemaker leads
Lead positions

Additional relevant MeSH terms:
Atrial Fibrillation
Sick Sinus Syndrome
Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Disease
Heart Block
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014