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


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Headache, Sinus

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

This study is currently recruiting patients.
Verified by Vitatron B.V. September 2005

Sponsors and Collaborators: Vitatron B.V.
Vitatron GmbH
Information provided by: Vitatron B.V.
ClinicalTrials.gov Identifier: NCT00161538

Purpose

The purpose of this study is to determine shich of 4 atrial 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 Syndrom
  Device: Pacing leads to be implanted according randomization.
 Device: Selection 9000 prevent AF an Diagnose AF
 Phase IV

MedlinePlus related topics:  Arrhythmia

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  456

Study start: July 2000;  Expected completion: October 2005

The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, faitigue, 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, Incidende of AF in total, Quality of Life, implant duration and complications will be evaluated.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00161538

Matthias E Reimers, Dipl. Documentalist      +49 2115293422    Matthias.reimers@vitatron.com
Steffen Gazarek, MD      +49 1729135662    steffen.gazarek@vitatron.com

Germany
      Ambulantes Herz-Zentrum Dresden, Dresden,  01099,  Germany; Recruiting
S. G. Spitzer, MD  +49 3518064102    ilona.feistkorn@praxisklinik-dresden.de 
S. G. Spitzer, MD,  Principal Investigator

      Klinikum Coburg, Coburg,  96450,  Germany; Recruiting
V. Schibgilla, MD  +49 9561220  Ext. 6348    v.schibgilla@t-online.de 
V. Schibgilla, MD,  Principal Investigator

      Werner-Forssmann-Krankenhaus GmbH, Eberswalde,  16225,  Germany; Recruiting
P. Wacker, MD  +49 3334690 
P. Wacker, MD,  Principal Investigator

      Städtisches Krankenhaus Friedrichshafen, Friedrichshafen,  88048,  Germany; Recruiting
D. Jäger, MD  +49 7541960 
D. Jäger, MD,  Principal Investigator

      Evangelisches Krankenhaus Kalk GmbH, Köhl,  51103,  Germany; Recruiting

      Kreiskrankenhaus Leer, Leer,  26789,  Germany; Recruiting
E. Stammwitz, MD  +49 491861701    kardiologie@kkhleer.de 
E. Stammwitz, MD,  Principal Investigator

      Helios-Klinikum Aue, Aue,  08280,  Germany; Recruiting

      Klinikum der Joh.-Wolfgang-Goethe-Universität, Frankfurt,  60596,  Germany; Recruiting

      Krankenhaus Maria Hilf, Mönchengladbach,  41063,  Germany; Recruiting
I. Szendey, MD  +49 21618921 
I. Szendey, MD,  Principal Investigator

      Universitätskrankenhaus Eppendorf, Hamburg,  20251,  Germany; Recruiting
A. Schuchert, MD  +49 40428030  Ext. 5765    schuchert@uke.uni-hamburg.de 
A. Schuchert, MD,  Principal Investigator

      Evang. Krankenhaus, Holzminden,  37603,  Germany; Recruiting
P. von Löwis of Menar, MD  +49 5531705209    P.Loewis@Evang.-Krhs-Holzminden.de 
P. von Löwis of Menar, MD,  Principal Investigator

      Klinikum Ingolstadt, Ingolstadt,  85049,  Germany; Recruiting

Study chairs or principal investigators

Stefan G. Spitzer, MD,  Principal Investigator,  Unaffiliated   

More Information

Publications

Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.

Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22.

Prakash A, Saksena S, Hill M, Krol RB, Munsif AN, Giorgberidze I, Mathew P, Mehra R. Acute effects of dual-site right atrial pacing in patients with spontaneous and inducible atrial flutter and fibrillation. J Am Coll Cardiol. 1997 Apr;29(5):1007-14.

Study ID Numbers:  PASTA V.1.5
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00161538
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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