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.

Study Overview

• Status: Completed
• Conditions: Sick Sinus Syndrome
• Intervention / Treatment: Device: Pacing leads to be implanted according randomization.; Device: Selection 9000 prevent AF an Diagnose AF

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.

• Study Type: Interventional
• Enrollment: 456
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Aue, Germany, 08280
    • Helios-Klinikum Aue
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Dresden, Germany, 01099
    • Ambulantes Herz-Zentrum Dresden
  • Eberswalde, Germany, 16225
    • Werner-Forssmann-Krankenhaus GmbH
  • Frankfurt, Germany, 60596
    • Klinikum der Joh.-Wolfgang-Goethe-Universität
  • Friedrichshafen, Germany, 88048
    • Städtisches Krankenhaus Friedrichshafen
  • Hamburg, Germany, 20251
    • Universitätskrankenhaus Eppendorf
  • Holzminden, Germany, 37603
    • Evang. Krankenhaus
  • Ingolstadt, Germany, 85049
    • Klinikum Ingolstadt
  • Köhl, Germany, 51103
    • Evangelisches Krankenhaus Kalk GmbH
  • Leer, Germany, 26789
    • Kreiskrankenhaus Leer
  • Mönchengladbach, Germany, 41063
    • Krankenhaus Maria Hilf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Collaborators: Vitatron GmbH
• Investigators: Principal Investigator: Stefan G. Spitzer, MD

Publications and helpful links

General 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. doi: 10.1016/S0140-6736(97)03425-9.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Study Completion: June 1, 2006

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (ESTIMATE): September 12, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2006
• Last Update Submitted That Met QC Criteria: October 19, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Cardiac Pacing, artificial; Pacemaker leads; Lead positions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Syndrome; Sick Sinus Syndrome
• Other Study ID Numbers: PASTA V.1.5