Clinical trial NCT00161538: Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
Official title: A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sick Sinus Syndrome
Keywords: Cardiac Pacing, artificial
Atrial fibrillation
Pacemaker leads
Lead positions
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
Collaborators: name: Vitatron GmbH
First posted: 2005-09-12
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
measure: 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant
Secondary outcomes:
measure: Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.
measure: Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants
Other outcomes:
Locations:
city: Aue
country: Germany
facility: Helios-Klinikum Aue
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dresden
country: Germany
facility: Ambulantes Herz-Zentrum Dresden
city: Eberswalde
country: Germany
facility: Werner-Forssmann-Krankenhaus GmbH
city: Frankfurt
country: Germany
facility: Klinikum der Joh.-Wolfgang-Goethe-Universität
city: Friedrichshafen
country: Germany
facility: Städtisches Krankenhaus Friedrichshafen
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Eppendorf
city: Holzminden
country: Germany
facility: Evang. Krankenhaus
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: Köhl
country: Germany
facility: Evangelisches Krankenhaus Kalk GmbH
city: Leer
country: Germany
facility: Kreiskrankenhaus Leer
city: Mönchengladbach
country: Germany
facility: Krankenhaus Maria Hilf
Study officials:
name: Stefan G. Spitzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1016/s0735-1097(97)00043-0.