Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
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ClinicalTrials.gov Identifier: NCT00161538 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : October 20, 2006
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 456 participants |
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 : | July 2000 |
Study Completion Date : | June 2006 |

- 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
- 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

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Ages Eligible for Study: | 18 Years to 0 Years |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161538
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 |
Principal Investigator: | Stefan G. Spitzer, MD |
ClinicalTrials.gov Identifier: | NCT00161538 |
Other Study ID Numbers: |
PASTA V.1.5 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | October 20, 2006 |
Last Verified: | October 2006 |
Cardiac Pacing, artificial Atrial fibrillation Pacemaker leads Lead positions |
Sick Sinus Syndrome Syndrome Disease Pathologic Processes Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Arrhythmia, Sinus Heart Block Cardiac Conduction System Disease |