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

• Sponsor: Medtronic BRC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00161538
• Collaborator: Vitatron GmbH (Industry)
• Enrollment: 456
• Locations: 12
• Duration (Months): 71
• Patients Per Site: 38
• Patients Per Site Per Month: 0.5

Study Details

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
• 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: Jul 1, 2000
• Study Completion Date: Jun 1, 2006

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Helios-Klinikum Aue	Aue		Germany	08280
2	Klinikum Coburg	Coburg		Germany	96450
3	Ambulantes Herz-Zentrum Dresden	Dresden		Germany	01099
4	Werner-Forssmann-Krankenhaus GmbH	Eberswalde		Germany	16225
5	Klinikum der Joh.-Wolfgang-Goethe-Universität	Frankfurt		Germany	60596
6	Städtisches Krankenhaus Friedrichshafen	Friedrichshafen		Germany	88048
7	Universitätskrankenhaus Eppendorf	Hamburg		Germany	20251
8	Evang. Krankenhaus	Holzminden		Germany	37603
9	Klinikum Ingolstadt	Ingolstadt		Germany	85049
10	Evangelisches Krankenhaus Kalk GmbH	Köhl		Germany	51103
11	Kreiskrankenhaus Leer	Leer		Germany	26789
12	Krankenhaus Maria Hilf	Mönchengladbach		Germany	41063

Sponsors and Collaborators

• Medtronic BRC
• Vitatron GmbH

Investigators

• Principal Investigator: Stefan G. Spitzer, MD,

Study Documents (Full-Text)

None provided.

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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00161538
• Other Study ID Numbers: PASTA V.1.5
• First Posted: Sep 12, 2005
• Last Update Posted: Oct 20, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: Cardiac Pacing, artificial; Atrial fibrillation; Pacemaker leads; Lead positions
• Additional relevant MeSH terms: Sick Sinus Syndrome; Syndrome

Study Results

No Results Posted as of Oct 20, 2006