Atrial FibrillationTripleANCT02051621
Therapy of Atrial Flutter by Afib Ablation
A study testing Antiarrhythmic drug, Cavo-tricuspid-isthmus-ablation and Pulmonary vein isolation in people with Atrial Fibrillation and Atrial Flutter, run by University of Rostock at 1 site in Germany.
Trial summary
Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Antiarrhythmic drug, Cavo-tricuspid-isthmus-ablation and Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Aug 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter
- > 21 years
Who cannot join
- - AFL as secondary to an accessory pathway
- Antiarrhythmic treatment for AF
- AF
- Previous AF ablation
- Dilatation of left atrium > 6 cm
- Cardiac surgery less < 3 weeks
Show all 9Show fewer
- Congenital heart disease
- Cardiac ischemia or coronary artery disease that needs intervention
- Life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country.
Ralph Schneider, MD contact
Dietmar Baensch, PhD, MD contact
Germany1 site, 1 recruiting
- Recruiting
Universitiy Medical Centre Rostock
Rostock, 18057
Dietmar Baensch, PhD, MD, dietmar.baensch@med.uni-rostock.de
Ralph Schneider, MD
About this study
Official title: Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).
Read the detailed description
Current clinical and experimental studies confirm the close relationship between atrial flutter (AFlut) and atrial fibrillation (Afib). After initiation of Afib this may organize under special intrinsic conditions or due to antiarrhythmic medication to AFlut so Afib may be supposed the underlying arrhythmia. Therefore after successful ablation of AFlut this reentrant circuit is not longer possible and Afib persists. After new occurrence of Afib a long diagnostic and therapeutic marathon begins with AF ablation at the end of all therapeutic efforts. This double burden for the patient and the health system can probably be avoided by directly and effectively treating the underlying arrhythmia AF.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Antiarrhythmic drug, Cavo-tricuspid-isthmus-ablation, Pulmonary vein isolation
- Keywords
- pulmonary vein isolation, isthmus ablation, recurrence
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drugDrug
Also called medical treatment of atrial flutter
medical treatment of atrial flutter with either flecainide (Tambocor ®) 100 mg twice daily, propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily electrical cardioversion as needed
Cavo-tricuspid-isthmus-ablationProcedure or surgery
Also called Ablation of atrial flutter
irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA
Pulmonary vein isolationProcedure or surgery
pulmonary vein angiography followed by antral pulmonary vein isolation using 3D-electroanatomical Mapping mapping system: Carto 3 (Biosense Webster, Diamond Bar, CA, USA) catheter used for irrigated RF-ablation: Navistar Thermocool R (D, E or F-type according to atrial dimensions), Biosense Webster, Diamond Bar, CA, USA
| Study group | Role | What they receive |
|---|---|---|
| Cavo-tricuspid-isthmus-ablation | Active comparator | Ablation of atrial flutter Receives: Procedure: Cavo-tricuspid-isthmus-ablation |
| Pulmonary vein isolation | Active comparator | pulmonary vein isolation Receives: Procedure: Pulmonary vein isolation |
| Antiarrhythmic drug | Active comparator | Medical treatment of atrial flutter with either class I antiarrhythmics (flecainide (Tambocor ®) 100 mg twice daily or propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily
cardioversion as needed Receives: Drug: Antiarrhythmic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number or patients with a recurrence of any atrial arrhythmia
Number (percentage) of patients with any atrial arrhythmia lasting longer than 30 s after ablation assessed by implantable loop recorder or 7-day-holter-ECG: AFL after AF ablation compared to the AFL ablation group and AF in both ablation groups
Measured: 2 years
Secondary outcomes (1)
Number of patients with atrial flutter recurrence
Number (percentage) of patients with any AFL episode after ablation or under medical therapy assessed by implantable loop recorder or 7-day-holter-ECG, compared between all 3 interventions (medical treatment vs. AFL Ablation vs. AF ablation)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startAug 2010
- Primary completionAug 2015 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc., Medtronic
- Responsible party
- Principal investigator, Dietmar Baensch, University of Rostock
- Investigators
- Dietmar Baensch, PhD, MD, Principal investigator, University Medical Centre Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051621
- Sponsor's protocol ID
- A201070
- Acronym
- TripleA
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider R, Lauschke J, Tischer T, Schneider C, Voss W, Moehlenkamp F, Glass A, Diedrich D, Bansch D. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial. Heart Rhythm. 2015 May;12(5):865-71. doi: 10.1016/j.hrthm.2015.01.040. Epub 2015 Jan 28.
PubMed 25638698
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
- ClinicalTrials.gov ID
- NCT02051621
- Acronym / sponsor ID
- TripleA / A201070
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- pulmonary vein isolation, isthmus ablation, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc., Medtronic
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 31 Jan 2014 (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.
Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).
Detailed description
Current clinical and experimental studies confirm the close relationship between atrial flutter (AFlut) and atrial fibrillation (Afib). After initiation of Afib this may organize under special intrinsic conditions or due to antiarrhythmic medication to AFlut so Afib may be supposed the underlying arrhythmia. Therefore after successful ablation of AFlut this reentrant circuit is not longer possible and Afib persists. After new occurrence of Afib a long diagnostic and therapeutic marathon begins with AF ablation at the end of all therapeutic efforts. This double burden for the patient and the health system can probably be avoided by directly and effectively treating the underlying arrhythmia AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cavo-tricuspid-isthmus-ablation | Active comparator | Procedure: Cavo-tricuspid-isthmus-ablationAblation of atrial flutter |
| Pulmonary vein isolation | Active comparator | Procedure: Pulmonary vein isolationpulmonary vein isolation |
| Antiarrhythmic drug | Active comparator | Drug: Antiarrhythmic drugMedical treatment of atrial flutter with either class I antiarrhythmics (flecainide (Tambocor ®) 100 mg twice daily or propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily cardioversion as needed |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter
- > 21 years
Key exclusion criteria (9 listed)
- - AFL as secondary to an accessory pathway
- Antiarrhythmic treatment for AF
- AF
- Previous AF ablation
- Dilatation of left atrium > 6 cm
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 |
|---|---|---|
| Antiarrhythmic drugAlso: medical treatment of atrial fluttermedical treatment of atrial flutter with either flecainide (Tambocor ®) 100 mg twice daily, propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily electrical cardioversion as needed | Drug | Antiarrhythmic drug |
| Cavo-tricuspid-isthmus-ablationAlso: Ablation of atrial flutterirrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA | Procedure or surgery | Cavo-tricuspid-isthmus-ablation |
| Pulmonary vein isolationpulmonary vein angiography followed by antral pulmonary vein isolation using 3D-electroanatomical Mapping mapping system: Carto 3 (Biosense Webster, Diamond Bar, CA, USA) catheter used for irrigated RF-ablation: Navistar Thermocool R (D, E or F-type according to atrial dimensions), Biosense Webster, Diamond Bar, CA, USA | Procedure or surgery | Pulmonary vein isolation |
Primary outcome
Number or patients with a recurrence of any atrial arrhythmia
Time frame: 2 years
Number (percentage) of patients with any atrial arrhythmia lasting longer than 30 s after ablation assessed by implantable loop recorder or 7-day-holter-ECG: AFL after AF ablation compared to the AFL ablation group and AF in both ablation groups
1 secondary outcome
Number of patients with atrial flutter recurrence
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Derived from this study: PubMed 25638698Schneider R, Lauschke J, Tischer T, Schneider C, Voss W, Moehlenkamp F, Glass A, Diedrich D, Bansch D. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial. Heart Rhythm. 2015 May;12(5):865-71. doi: 10.1016/j.hrthm.2015.01.040. Epub 2015 Jan 28.
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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.
Ralph Schneider, MD contact
Dietmar Baensch, PhD, MD contact
Dietmar Baensch, PhD, MD principal investigator
University Medical Centre Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiarrhythmic drug, Cavo-tricuspid-isthmus-ablation and Pulmonary vein isolation in people with Atrial Fibrillation and Atrial Flutter, run by University of Rostock 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 9 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 31 Jan 2014. 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 Ralph Schneider, MD (ralph.schneider@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number or patients with a recurrence of any atrial arrhythmia (time frame: 2 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 NCT02051621, which also lists 1 linked publication.
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 31 Jan 2014.