Atrial FibrillationNCT00215761
Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers and Drug Therapy
An observational study of Atrial Fibrillation, run by Atrial Fibrillation Network at 1 site in Germany.
Trial summary
Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing. All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or ACE-Inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 263 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Dec 2008
- Phase
- Observational
- 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
Study population: Paroxysmal symptomatic atrial fibrillation with implemented dual-chamber pacemakers
Who may be able to join
- Paroxysmal symptomatic atrial fibrillation
- Implantation of a dual-chamber pacemaker because of generally accepted pacing indications
- Symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
- Symptomatic sinuatrial block
- Advanced AV-block (AV block II / III)
- Binodal disease: Sick-sinus-syndrome and advanced AV-block
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- AV-Nodal-Ablation in combination with pacemaker therapy ( "Ablate \& Pace").
- The implantation of a fully functional DDDR Selection 9000, Prevent AF, T 70 DR pacemaker (Vitatron) e.g. normal impedance, stimulation thresholds and sensing values) 2 - 4 months after implantation
- Written informed consent of the patient
- Age > 18 years
Who cannot join
- Chronic heart failure (NYHA III/IV)
- Acute myocardial infarction < 6 months
- Hypertrophic obstructive cardiomyopathy
- Symptomatic hypo- or hyperthyroidism
- Instable angina pectoris
- Cardiogenic shock
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- Patients with diabetes mellitus and recurrent hypoglycaemia
- Pregnancy or breast feeding
- Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted
- Reduced life expectancy (< 6 months)
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
- Evidence of an uncooperative attitude
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Cardiac Center
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: A Multicenter Study to Investigate Preventive Pacing in Combination With Antiarrhythmic Beta-Blocker Oder AT-I-/ACE-inhibitor Therapy on the Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers
Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing. All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or ACE-Inhibitor.
Read the detailed description
Implantable pacemaker devices are available with specific atrial pacing algorithms designed to prevent atrial arrhythmias (Preventive stimulation). These algorithms work by increasing the atrial pacing rate to achieve continuous overdrive pacing or by responding to triggers such as premature atrial complexes.
Different investigation's showed that preventive atrial pacing was associated with a 30 to 50 % reduction in the risk of recurrence of AF, compared with no pacing. But a complete recurrence-free long-term effect is not reached.
A hybrid therapy consisting of a combination of preventive atrial stimulation and pharmacologic therapy maybe useful in restoring sinus rhythm. The HOPE-(Heart Outcomes Prevention Evaluation)-Trial showed a overwhelming evidence that, in a broad range of high-risk patients, an ACE-Inhibitor (Ramipril) prevents cardiovascular death, stroke, and heart failure. AF leads to an activation of the renin-angiotensin system (RAS), which seems to play an important role in atrial remodeling. Both experimental and clinical data have confirmed the pro-arrhythmic role of the RAS and demonstrated an anti-arrhythmic effect of ACE- and AT-I-Inhibitors. Madrid et al. showed that a combination of the AT-I-Inhibitor irbesartan plus amiodarone decreased the rate of AF recurrences, with a dose-dependent effect, in AF patients. ACE- and AT-I-Inhibitors represent new and efficient therapeutical options to contrast the nearly inevitable progression of this arrhythmia towards its permanent form. Beta-Blockers are a common pharmacologic therapy in AF patients.
The aim of the BACE-PACE-Trial is to investigate preventive pacing stimulation (PS) vs. standard DDD[R]-60-Stimulation (ST) in combination with antiarrhythmic Beta-Blocker or ACE-inhibitor therapy on the recurrence of atrial fibrillation in patients with dual-chamber pacemakers
The Responder (patients without AF recurrence, respectively with a significant reduction in AF burden) are compared to the standard stimulation. A clinically relevance meant a reduction in AF burden of more than 25 % (experts consensus).
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Preventive stimulation, Pacemaker
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic BRC
- Responsible party
- Sponsor
- Investigators
- Andreas Schuchert, Prof. Dr., Principal investigator, University Cardiac Center, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215761
- Sponsor's protocol ID
- AFNET-B05
- Status last verified
- Sep 2012
- First submitted
- 14 Sep 2005
- Last updated
- 10 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Investigate Preventive Pacing in Combination With Antiarrhythmic Beta-Blocker Oder AT-I-/ACE-inhibitor Therapy on the Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers
- ClinicalTrials.gov ID
- NCT00215761
- Acronym / sponsor ID
- AFNET-B05
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Preventive stimulation, Pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Collaborators
- Medtronic BRC
- Study start
- Jan 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 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.
Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing. All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or ACE-Inhibitor.
Detailed description
Implantable pacemaker devices are available with specific atrial pacing algorithms designed to prevent atrial arrhythmias (Preventive stimulation). These algorithms work by increasing the atrial pacing rate to achieve continuous overdrive pacing or by responding to triggers such as premature atrial complexes.
Different investigation's showed that preventive atrial pacing was associated with a 30 to 50 % reduction in the risk of recurrence of AF, compared with no pacing. But a complete recurrence-free long-term effect is not reached.
A hybrid therapy consisting of a combination of preventive atrial stimulation and pharmacologic therapy maybe useful in restoring sinus rhythm. The HOPE-(Heart Outcomes Prevention Evaluation)-Trial showed a overwhelming evidence that, in a broad range of high-risk patients, an ACE-Inhibitor (Ramipril) prevents cardiovascular death, stroke, and heart failure. AF leads to an activation of the renin-angiotensin system (RAS), which seems to play an important role in atrial remodeling. Both experimental and clinical data have confirmed the pro-arrhythmic role of the RAS and demonstrated an anti-arrhythmic effect of ACE- and AT-I-Inhibitors. Madrid et al. showed that a combination of the AT-I-Inhibitor irbesartan plus amiodarone decreased the rate of AF recurrences, with a dose-dependent effect, in AF patients. ACE- and AT-I-Inhibitors represent new and efficient therapeutical options to contrast the nearly inevitable progression of this arrhythmia towards its permanent form. Beta-Blockers are a common pharmacologic therapy in AF patients.
The aim of the BACE-PACE-Trial is to investigate preventive pacing stimulation (PS) vs. standard DDD[R]-60-Stimulation (ST) in combination with antiarrhythmic Beta-Blocker or ACE-inhibitor therapy on the recurrence of atrial fibrillation in patients with dual-chamber pacemakers
The Responder (patients without AF recurrence, respectively with a significant reduction in AF burden) are compared to the standard stimulation. A clinically relevance meant a reduction in AF burden of more than 25 % (experts consensus).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paroxysmal symptomatic atrial fibrillation with implemented dual-chamber pacemakers
Key inclusion criteria (10 listed)
- Paroxysmal symptomatic atrial fibrillation
- Implantation of a dual-chamber pacemaker because of generally accepted pacing indications
- Symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
- Symptomatic sinuatrial block
- Advanced AV-block (AV block II / III)
Key exclusion criteria (12 listed)
- Chronic heart failure (NYHA III/IV)
- Acute myocardial infarction < 6 months
- Hypertrophic obstructive cardiomyopathy
- Symptomatic hypo- or hyperthyroidism
- Instable angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Sep 2012.
- German Atrial Fibrillation NetworkLink provided by the sponsor.
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Atrial Fibrillation (AF)
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.
Andreas Schuchert, Prof. Dr. principal investigator
University Cardiac Center, Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Atrial Fibrillation Network at 1 site 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 10 inclusion and 12 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
Where can I read the original study information?
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 10 Sep 2012.