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

• ClinicalTrials.gov Identifier: NCT00161538
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: October 20, 2006
• Sponsor: Medtronic BRC
• Collaborator: Vitatron GmbH
• Information provided by: Medtronic BRC

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.

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 0 Years
• Sexes Eligible for Study: All
• 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

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:

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, Schüller 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.

• ClinicalTrials.gov Identifier: NCT00161538
• Other Study ID Numbers: PASTA V.1.5
• First Posted: September 12, 2005
• 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:

Sick Sinus Syndrome; Syndrome; Disease; Pathologic Processes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease