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

Sick Sinus Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161538
• Other study ID #: PASTA V.1.5
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: October 19, 2006
• Start date: July 2000
• Est. completion date: June 2006

Study information

• Verified date: October 2006
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Sick Sinus Syndrome
• Syndrome

Intervention

Device:
• Pacing leads to be implanted according randomization.

• Selection 9000 prevent AF an Diagnose AF

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic BRC	Vitatron GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant
Secondary	Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.
Secondary	Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants