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

Primary Purpose

Sick Sinus Syndrome

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Pacing leads to be implanted according randomization.
Selection 9000 prevent AF an Diagnose AF
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helios-Klinikum Aue
  • Klinikum Coburg
  • Ambulantes Herz-Zentrum Dresden
  • Werner-Forssmann-Krankenhaus GmbH
  • Klinikum der Joh.-Wolfgang-Goethe-Universität
  • Städtisches Krankenhaus Friedrichshafen
  • Universitätskrankenhaus Eppendorf
  • Evang. Krankenhaus
  • Klinikum Ingolstadt
  • Evangelisches Krankenhaus Kalk GmbH
  • Kreiskrankenhaus Leer
  • Krankenhaus Maria Hilf

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
October 19, 2006
Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00161538
Brief Title
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
Official Title
A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH

4. Oversight

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome
Keywords
Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pacing leads to be implanted according randomization.
Intervention Type
Device
Intervention Name(s)
Selection 9000 prevent AF an Diagnose AF
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.
Title
Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan G. Spitzer, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios-Klinikum Aue
City
Aue
ZIP/Postal Code
08280
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Ambulantes Herz-Zentrum Dresden
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Werner-Forssmann-Krankenhaus GmbH
City
Eberswalde
ZIP/Postal Code
16225
Country
Germany
Facility Name
Klinikum der Joh.-Wolfgang-Goethe-Universität
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Städtisches Krankenhaus Friedrichshafen
City
Friedrichshafen
ZIP/Postal Code
88048
Country
Germany
Facility Name
Universitätskrankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Evang. Krankenhaus
City
Holzminden
ZIP/Postal Code
37603
Country
Germany
Facility Name
Klinikum Ingolstadt
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk GmbH
City
Köhl
ZIP/Postal Code
51103
Country
Germany
Facility Name
Kreiskrankenhaus Leer
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Krankenhaus Maria Hilf
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
9652562
Citation
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. doi: 10.1016/S0140-6736(97)03425-9.
Results Reference
background
PubMed Identifier
3394616
Citation
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. doi: 10.1016/0002-8703(88)90244-x.
Results Reference
background
PubMed Identifier
9120152
Citation
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. doi: 10.1016/s0735-1097(97)00043-0.
Results Reference
background

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

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