Sick Sinus SyndromePhase 4NCT00161538
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
A Phase 4 study testing Pacing leads to be implanted according randomization. and Selection 9000 prevent AF an Diagnose AF in people with Sick Sinus Syndrome, run by Medtronic BRC at 12 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome
- What is being tested?
- Pacing leads to be implanted according randomization. and Selection 9000 prevent AF an Diagnose AF
- Type of treatment
- Medical device
- How many people
- 456 participants
- Where
- 12 sitesGermany
- Study dates
- Jul 2000to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Helios-Klinikum Aue
Aue, 08280
Klinikum Coburg
Coburg, 96450
Ambulantes Herz-Zentrum Dresden
Dresden, 01099
Werner-Forssmann-Krankenhaus GmbH
Eberswalde, 16225
Klinikum der Joh.-Wolfgang-Goethe-Universität
Frankfurt, 60596
Städtisches Krankenhaus Friedrichshafen
Friedrichshafen, 88048
Universitätskrankenhaus Eppendorf
Hamburg, 20251
Evang. Krankenhaus
Holzminden, 37603
Klinikum Ingolstadt
Ingolstadt, 85049
Evangelisches Krankenhaus Kalk GmbH
Köhl, 51103
Kreiskrankenhaus Leer
Leer, 26789
Krankenhaus Maria Hilf
Mönchengladbach, 41063
About this study
Official title: A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome
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.
Read the 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.
- Conditions
- Sick Sinus Syndrome
- Being tested
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Keywords
- Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing leads to be implanted according randomization.Device
Selection 9000 prevent AF an Diagnose AFDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2000
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitatron GmbH
- Investigators
- Stefan G. Spitzer, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161538
- Sponsor's protocol ID
- PASTA V.1.5
- Status last verified
- Oct 2006
- First submitted
- 9 Sep 2005
- Last updated
- 20 Oct 2006
- Results posted
- No
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. doi: 10.1016/S0140-6736(97)03425-9.
PubMed 9652562Rosenqvist 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.
PubMed 3394616Prakash 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.
PubMed 9120152
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome
- ClinicalTrials.gov ID
- NCT00161538
- Acronym / sponsor ID
- PASTA V.1.5
- Conditions
- Sick Sinus Syndrome
- Keywords
- Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Collaborators
- Vitatron GmbH
- Study start
- Jul 2000
- Study completion
- Jun 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sick Sinus Syndrome
- Symptomatic sinus bradycardia
- Symptomatic SA block
- Bradycardia-Tachycardia-Syndrom
- Binodal diseases, Sinus Node Syndrome and high degree AV-Block
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing leads to be implanted according randomization. | Device | – |
| Selection 9000 prevent AF an Diagnose AF | Device | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2006.
- Background: PubMed 9652562Andersen 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.
- Background: PubMed 3394616Rosenqvist 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.
- Background: PubMed 9120152Prakash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan G. Spitzer, MD principal investigator
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pacing leads to be implanted according randomization. and Selection 9000 prevent AF an Diagnose AF in people with Sick Sinus Syndrome, run by Medtronic BRC at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00161538, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2006; AzTrials last refreshed its copy on 8 Nov 2026.