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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00161538
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 20, 2006
Vitatron GmbH
Information provided by:
Medtronic BRC

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2000
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161538

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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
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Principal Investigator: Stefan G. Spitzer, MD
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ClinicalTrials.gov Identifier: NCT00161538    
Other Study ID Numbers: PASTA V.1.5
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 20, 2006
Last Verified: October 2006
Keywords provided by Medtronic BRC:
Cardiac Pacing, artificial
Atrial fibrillation
Pacemaker leads
Lead positions
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmia, Sinus
Heart Block
Cardiac Conduction System Disease