Atrial FibrillationNCT00157807
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
A study testing bipolar radiofrequency ablation of persistent and permanent AF in people with Atrial Fibrillation and Coronary Artery Disease, run by Medtronic Cardiac Surgery at 5 sites in Germany.
Trial summary
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- bipolar radiofrequency ablation of persistent and permanent AF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesGermany
- Study dates
- Sep 2005to Aug 2013
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent atrial fibrillation
- Permanent atrial fibrillation
- Mitral valve defect
- Tricuspid valve defect
- Aortic valve defect
- Coronary artery disease
Who cannot join
- Pregnancy
- Age < 18 or > 75 Years
- Emergency surgery
- Left dominant coronary circulation (relative contraindication)
- Coronary arteries of the posterior wall without pathological findings: No inclusion
- Stenosis of the posterior wall vessels, supplied with a CABG (coronary artery bypass grafting): Inclusion possible
Show all 17Show fewer
- Left ventricular ejection fraction < 30%
- Size of the left atrium > 7 cm
- Thrombosis of the left atrial appendage
- Leads in the coronary sinus
- Atrial flutter
- Infective endocarditis
- Reoperation
- Participation in other studies
- Life expectancy of less than 12 months
- Psychiatric disorders
- Hyperthyreosis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinik für Herz- und Thoraxchirurgie
Bochum, North Rhine-Westphalia, 44789
Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
Bonn, North Rhine-Westphalia, 53105
Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony, 06120
Klinik für Herz-, Thorax- und Gefäßchirurgie
Lahr, Baden-Wurttemberg, 77933
Klinikum der Universität Muenchen Großhadern Cardiac Surgery
München, Bavaria, 81377
About this study
Official title: Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- bipolar radiofrequency ablation of persistent and permanent AF
- Keywords
- Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar radiofrequency ablation of persistent and permanent AFProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| No Ablation | No intervention | Not described |
| bipolar radiofrequency ablation of persistent and permanent AF | Other | intra operative bipolar RF ablation of persistent and permanent AF Receives: Procedure: bipolar radiofrequency ablation of persistent and permanent AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 12 months
Cost of care
Measured: 12 months
Secondary outcomes (2)
Atrial fibrillation
Measured: 12 months
Echo parameters
Measured: 12 months
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 startSep 2005
- Primary completionJun 2008
- Study completionAug 2013
Why it stopped: no eligible patients can be found
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Calin Vicol, Professor, Principal investigator, Klinikum der Universität München Großhadern Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157807
- Sponsor's protocol ID
- CEN_G_CS_1
- Status last verified
- Feb 2017
- First submitted
- 8 Sep 2005
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial
- ClinicalTrials.gov ID
- NCT00157807
- Acronym / sponsor ID
- CEN_G_CS_1
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Keywords
- Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no eligible patients can be found
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2013 (actual)
- 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 clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Ablation | No intervention | – |
| bipolar radiofrequency ablation of persistent and permanent AF | Other | Procedure: bipolar radiofrequency ablation of persistent and permanent AFintra operative bipolar RF ablation of persistent and permanent AF |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent atrial fibrillation
- Permanent atrial fibrillation
- Mitral valve defect
- Tricuspid valve defect
- Aortic valve defect
Key exclusion criteria (17 listed)
- Pregnancy
- Age < 18 or > 75 Years
- Emergency surgery
- Left dominant coronary circulation (relative contraindication)
- Coronary arteries of the posterior wall without pathological findings: No inclusion
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 |
|---|---|---|
| bipolar radiofrequency ablation of persistent and permanent AF | Procedure or surgery | bipolar radiofrequency ablation of persistent and permanent AF |
Primary outcome
Quality of life
Time frame: 12 months
Cost of care
Time frame: 12 months
2 secondary outcomes
Atrial fibrillation
Time frame: 12 months
Echo parameters
Time frame: 12 months
Results and safety
The study was stopped early (reason given: no eligible patients can be found). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Klinikum der UniversitätLink provided by the sponsor.
- HerzchirurgieLink provided by the sponsor.
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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.
Calin Vicol, Professor principal investigator
Klinikum der Universität München Großhadern Cardiac Surgery
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bipolar radiofrequency ablation of persistent and permanent AF in people with Atrial Fibrillation and Coronary Artery Disease, run by Medtronic Cardiac Surgery at 5 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 17 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: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
The study was stopped early (reason given: no eligible patients can be found). Results are not available in the source record.
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?
Quality of life (time frame: 12 months). 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?
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 8 May 2025.