Paroxysmal Atrial FibrillationNCT02238392
Adenosine vs AF Termination for Paroxysmal AF Ablation
A study testing Adenosine test and Termination of AF in people with Paroxysmal Atrial Fibrillation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Adenosine test and Termination of AF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with paroxysmal AF
- de-novo AF ablation
- age > 18 years
Who cannot join
- persistent AF
- previous cardioversion
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Mainz, Department of Medicine II
Mainz, 55131
About this study
Official title: Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.
Read the detailed description
Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.
A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Adenosine test, Termination of AF
- Keywords
- paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine testProcedure or surgery
Testing dormant conduction after PVI
Termination of AFProcedure or surgery
Testing AF iducibility and ermination of
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Adenosine testing after PVI and elimination of dormant conduction Receives: Procedure: Adenosine test |
| Group B - Termination of AF | Active comparator | Termination of atrial fibrillation by catheter ablation Receives: Procedure: Termination of AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival
arrhythmia-free outcome during 1 year after the procedure
Measured: 1 year
Secondary outcomes (1)
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
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 Paroxysmal 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Rostock, Johannes Gutenberg University Mainz
- Investigators
- Thomas Rostock, MD, Principal investigator, University Hospital Mainz, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238392
- Sponsor's protocol ID
- 1/2014
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Theis C, Konrad T, Mollnau H, Sonnenschein S, Kampfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Munzel T, Rostock T. Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial Fibrillation: A Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1080-7. doi: 10.1161/CIRCEP.115.002786. Epub 2015 Aug 21.
PubMed 26297786
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02238392
- Acronym / sponsor ID
- 1/2014
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Sep 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.
This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.
Detailed description
Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.
A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Adenosine testAdenosine testing after PVI and elimination of dormant conduction |
| Group B - Termination of AF | Active comparator | Procedure: Termination of AFTermination of atrial fibrillation by catheter ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with paroxysmal AF
- de-novo AF ablation
- age > 18 years
Key exclusion criteria (2 listed)
- persistent AF
- previous cardioversion
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 |
|---|---|---|
| Adenosine testTesting dormant conduction after PVI | Procedure or surgery | Group A |
| Termination of AFTesting AF iducibility and ermination of | Procedure or surgery | Group B - Termination of AF |
Primary outcome
Arrhythmia-free survival
Time frame: 1 year
arrhythmia-free outcome during 1 year after the procedure
1 secondary outcome
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
Time frame: 1 year
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 12 Sep 2014.
- Derived from this study: PubMed 26297786Theis C, Konrad T, Mollnau H, Sonnenschein S, Kampfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Munzel T, Rostock T. Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial Fibrillation: A Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1080-7. doi: 10.1161/CIRCEP.115.002786. Epub 2015 Aug 21.
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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.
Thomas Rostock, MD principal investigator
University Hospital Mainz, Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine test and Termination of AF in people with Paroxysmal Atrial Fibrillation, run by Johannes Gutenberg University Mainz 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 2 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 12 Sep 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?
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.
What does the primary outcome measure?
Arrhythmia-free survival (time frame: 1 year). 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 NCT02238392, 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 12 Sep 2014.