Atrial FibrillationPhase 4NCT00196209
Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation
A Phase 4 study testing catheter ablation and external electric cardioversion in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- catheter ablation and external electric cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Dec 2009
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >20 years and <75 years
- documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
- documented sufficient anticoagulation for at least 4 weeks before inclusion
Who cannot join
- Paroxysmal atrial fibrillation
- NYHA IV (if recompensation is not possible)
- Contraindication for warfarin
- Disturbance of blood coagulation
- Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
- Reversible causes of atrial fibrillation (i.e. hyperthyroidism)
Show all 11Show fewer
- Pregnancy
- LA-diameter > 55mm
- LV-function < 30% EF
- Aortic or mitral stenosis or regurgitation III°-IV°
- Prosthetic valves
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, 80636
Heidi L. Estner, MD, 0049 89 1218-2020, estner@dhm.mhn.de
Heidi L Estner, MD
About this study
Official title: Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
Read the detailed description
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation, external electric cardioversion
- Keywords
- atrial fibrillation, catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationProcedure or surgery
catheter ablation to treat persistent atrial fibrillation
external electric cardioversionProcedure or surgery
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | catheter ablation to treat persistent atrial fibrillation Receives: Procedure: catheter ablation |
| 2 | Experimental | cardioversion and drug prophylaxis to treat persistent atrial fibrillation Receives: Procedure: external electric cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death).
Measured: 6 months
Secondary outcomes (6)
success-rate immediately after intervention
Measured: success-rate immediately after intervention
need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion)
Measured: 2-3 months
burden of atrial fibrillation in a 7-day-holter after 6 months
Measured: 6 months
significant improvement in exercise capacity (measured by spiroergometry)
Measured: 6 months
decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention
Measured: 6 months
improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Isabel Deisenhofer, MD, Study chair, Deutsches Herzzentrum MuenchenHeidi L Estner, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196209
- Sponsor's protocol ID
- GE IDE No. C00705
- Status last verified
- Mar 2008
- First submitted
- 12 Sep 2005
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00196209
- Acronym / sponsor ID
- GE IDE No. C00705
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 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 aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
Detailed description
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: catheter ablationcatheter ablation to treat persistent atrial fibrillation |
| 2 | Experimental | Procedure: external electric cardioversioncardioversion and drug prophylaxis to treat persistent atrial fibrillation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >20 years and <75 years
- documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
- documented sufficient anticoagulation for at least 4 weeks before inclusion
Key exclusion criteria (11 listed)
- Paroxysmal atrial fibrillation
- NYHA IV (if recompensation is not possible)
- Contraindication for warfarin
- Disturbance of blood coagulation
- Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
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 |
|---|---|---|
| catheter ablationcatheter ablation to treat persistent atrial fibrillation | Procedure or surgery | 1 |
| external electric cardioversionexternal cardioversion and drug prophylaxis to treat persistent atrial fibrillation | Procedure or surgery | 2 |
Primary outcome
Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death).
Time frame: 6 months
6 secondary outcomes
success-rate immediately after intervention
Time frame: success-rate immediately after intervention
need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion)
Time frame: 2-3 months
burden of atrial fibrillation in a 7-day-holter after 6 months
Time frame: 6 months
significant improvement in exercise capacity (measured by spiroergometry)
Time frame: 6 months
decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention
Time frame: 6 months
improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
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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.
Isabel Deisenhofer, MD study chair
Deutsches Herzzentrum Muenchen
Heidi L Estner, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing catheter ablation and external electric cardioversion in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen 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 3 inclusion and 11 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 19 Mar 2008. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi L Estner, MD (0049 89 1218 2020, estner@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death). (time frame: 6 months). 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 19 Mar 2008.