Atrial FibrillationNCT00806689
Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy
An observational study of Atrial Fibrillation, run by University of Luebeck at 1 site in Germany.
Trial summary
24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac rhythm monitor implantation and Reveal® XT 9525
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jul 2011
- 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: patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.
Who may be able to join
- patients in atrial fibrillation (AF duration >4 months)being scheduled for cardiac surgery
- patients with lone atrial fibrillation being scheduled for surgical AF treatment
Who cannot join
- failure to provide informed consent
- current participation in another clinical trial
- organic cause of atrial fibrillation (hyperthyroidism etc.)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
Lübeck, Schleswig-Holstein, 23538
Hans-H. Sievers, M.D., 0049451500 ext. 2108, h.sievers@herzchirurgie-luebeck.de
Thorsten Hanke, M.D., 0049451500 ext. 2108, Thorsten.Hanke@uk-sh.de
About this study
24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.
In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac rhythm monitor implantation, Reveal® XT 9525
- Keywords
- heart rhythm surveillance, follow-up, atrial fibrillation success
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rhythm monitor implantationProcedure or surgery
Also called Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
Reveal® XT 9525Device
During cardiac surgery after stand alone or concomitant ablation procedure, an insertable loop recorder will be implanted subcutaneously in left pectoral region. After surgery, patients will be monitored regularly in a quarterly basis by performing telemetry of the device in the outpatient clinic. Furthermore, home telemetry will be performed once a month for optimal heart rhythm observation.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure Receives: Procedure: Cardiac rhythm monitor implantation; Device: Reveal® XT 9525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation burden development after surgical ablation therapy
Measured: 3 years
Secondary outcomes (1)
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2008 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Hans-H. Sievers, M.D., Study director, Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germanyThorsten Hanke, M.D., Principal investigator, Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germanyUlrich Stierle, M.D., Study chair, Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806689
- Sponsor's protocol ID
- 08-046
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanke T, Charitos EI, Stierle U, Karluss A, Kraatz E, Graf B, Hagemann A, Misfeld M, Sievers HH. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. 2009 Sep 15;120(11 Suppl):S177-84. doi: 10.1161/CIRCULATIONAHA.108.838474.
PubMed 19752365Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. Atrial fibrillation burden estimates derived from intermittent rhythm monitoring are unreliable estimates of the true atrial fibrillation burden. Pacing Clin Electrophysiol. 2014 Sep;37(9):1210-8. doi: 10.1111/pace.12389. Epub 2014 Mar 25.
PubMed 24665972Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. How often should we monitor for reliable detection of atrial fibrillation recurrence? Efficiency considerations and implications for study design. PLoS One. 2014 Feb 12;9(2):e89022. doi: 10.1371/journal.pone.0089022. eCollection 2014.
PubMed 24563690Charitos EI, Stierle U, Ziegler PD, Baldewig M, Robinson DR, Sievers HH, Hanke T. A comprehensive evaluation of rhythm monitoring strategies for the detection of atrial fibrillation recurrence: insights from 647 continuously monitored patients and implications for monitoring after therapeutic interventions. Circulation. 2012 Aug 14;126(7):806-14. doi: 10.1161/CIRCULATIONAHA.112.098079. Epub 2012 Jul 23.
PubMed 22824434
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy
- ClinicalTrials.gov ID
- NCT00806689
- Acronym / sponsor ID
- 08-046
- Conditions
- Atrial Fibrillation
- Keywords
- heart rhythm surveillance, follow-up, atrial fibrillation success
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 11 Dec 2008 (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.
24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.
In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | Procedure: Cardiac rhythm monitor implantation, Device: Reveal® XT 9525Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.
Key inclusion criteria (2 listed)
- patients in atrial fibrillation (AF duration >4 months)being scheduled for cardiac surgery
- patients with lone atrial fibrillation being scheduled for surgical AF treatment
Key exclusion criteria (3 listed)
- failure to provide informed consent
- current participation in another clinical trial
- organic cause of atrial fibrillation (hyperthyroidism etc.)
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 |
|---|---|---|
| Cardiac rhythm monitor implantationAlso: Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USApost surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy | Procedure or surgery | Cardiac surgery patients |
| Reveal® XT 9525During cardiac surgery after stand alone or concomitant ablation procedure, an insertable loop recorder will be implanted subcutaneously in left pectoral region. After surgery, patients will be monitored regularly in a quarterly basis by performing telemetry of the device in the outpatient clinic. Furthermore, home telemetry will be performed once a month for optimal heart rhythm observation. | Device | Cardiac surgery patients |
Primary outcome
Atrial fibrillation burden development after surgical ablation therapy
Time frame: 3 years
1 secondary outcome
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Results publication: PubMed 19752365Hanke T, Charitos EI, Stierle U, Karluss A, Kraatz E, Graf B, Hagemann A, Misfeld M, Sievers HH. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. 2009 Sep 15;120(11 Suppl):S177-84. doi: 10.1161/CIRCULATIONAHA.108.838474.
- Derived from this study: PubMed 24665972Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. Atrial fibrillation burden estimates derived from intermittent rhythm monitoring are unreliable estimates of the true atrial fibrillation burden. Pacing Clin Electrophysiol. 2014 Sep;37(9):1210-8. doi: 10.1111/pace.12389. Epub 2014 Mar 25.
- Derived from this study: PubMed 24563690Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. How often should we monitor for reliable detection of atrial fibrillation recurrence? Efficiency considerations and implications for study design. PLoS One. 2014 Feb 12;9(2):e89022. doi: 10.1371/journal.pone.0089022. eCollection 2014.
- Derived from this study: PubMed 22824434Charitos EI, Stierle U, Ziegler PD, Baldewig M, Robinson DR, Sievers HH, Hanke T. A comprehensive evaluation of rhythm monitoring strategies for the detection of atrial fibrillation recurrence: insights from 647 continuously monitored patients and implications for monitoring after therapeutic interventions. Circulation. 2012 Aug 14;126(7):806-14. doi: 10.1161/CIRCULATIONAHA.112.098079. Epub 2012 Jul 23.
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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.
Hans-H. Sievers, M.D. study director
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Thorsten Hanke, M.D. principal investigator
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Ulrich Stierle, M.D. study chair
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, 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 University of Luebeck 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thorsten Hanke, MD (0049-451-500 ext. 2108, Thorsten.Hanke@uk-sh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden development after surgical ablation therapy (time frame: 3 years). 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 NCT00806689, which also lists 4 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 2 Jul 2010.