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

NCT ID: NCT00161538

Last Updated: 2006-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2006-06-30

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:

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.

Conditions

Sick Sinus Syndrome

Keywords

Cardiac Pacing, artificial; Atrial fibrillation; Pacemaker leads; Lead positions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Pacing leads to be implanted according randomization.

Intervention Type: DEVICE

Selection 9000 prevent AF an Diagnose AF

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitatron GmbH

INDUSTRY

Sponsor Role: collaborator

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Stefan G. Spitzer, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Helios-Klinikum Aue

Aue, , Germany

Klinikum Coburg

Coburg, , Germany

Ambulantes Herz-Zentrum Dresden

Dresden, , Germany

Werner-Forssmann-Krankenhaus GmbH

Eberswalde, , Germany

Klinikum der Joh.-Wolfgang-Goethe-Universität

Frankfurt, , Germany

Städtisches Krankenhaus Friedrichshafen

Friedrichshafen, , Germany

Universitätskrankenhaus Eppendorf

Hamburg, , Germany

Evang. Krankenhaus

Holzminden, , Germany

Klinikum Ingolstadt

Ingolstadt, , Germany

Evangelisches Krankenhaus Kalk GmbH

Köhl, , Germany

Kreiskrankenhaus Leer

Leer, , Germany

Krankenhaus Maria Hilf

Mönchengladbach, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 9652562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3394616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9120152 (View on PubMed)

Other Identifiers

PASTA V.1.5

Identifier Type: -

Identifier Source: org_study_id