Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation - Full Text View

Sponsor:	Medtronic BRC
Collaborator:	Vitatron GmbH
Information provided by:	Medtronic BRC
ClinicalTrials.gov Identifier:	NCT00161538

Purpose

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	Intervention	Phase
Sick Sinus Syndrome	Device: Pacing leads to be implanted according randomization. Device: Selection 9000 prevent AF an Diagnose AF	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Medtronic BRC:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	456
Study Start Date:	July 2000
Estimated Study Completion Date:	June 2006

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:

Free atrial wall
right atrial appendage
coronary sinus-os
Dual site right atrial pacing: b) plus c).

The following primary parameters will be evaluated during the study period of 2 years after implantation:

Amounts of AF episodes with a duration of > 48 hours
Amounts of AF episodes with a duration of > 30 minutes
Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161538

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, 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.

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 History of Changes
Other Study ID Numbers:	PASTA V.1.5
Study First Received:	September 9, 2005
Last Updated:	October 19, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:

Cardiac Pacing, artificial
Atrial fibrillation
Pacemaker leads
Lead positions

Additional relevant MeSH terms:

Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases

Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on February 09, 2012