Atrial FibrillationADLINENCT02059369
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
A study testing PVI+CFAE+DCC and PVI, CFAE, anterior and roof line, DCC in people with Atrial Fibrillation and Recurrence, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Recurrence
- What is being tested?
- PVI+CFAE+DCC and PVI, CFAE, anterior and roof line, DCC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic persistent AF
- After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia
Who cannot join
- Left atrial thrombus
Trial locations and contacts
1 site in 1 country.
About this study
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.
- Conditions
- Atrial Fibrillation, Recurrence
- Being tested
- PVI+CFAE+DCC, PVI, CFAE, anterior and roof line, DCC
- Keywords
- Atrial fibrillation, Recurrence, CFAE, linear ablation
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI+CFAE+DCCProcedure or surgery
pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists
PVI, CFAE, anterior and roof line, DCCProcedure or surgery
PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists
| Study group | Role | What they receive |
|---|---|---|
| CFAE ablation | Active comparator | Intervention: Complex fractionated atrial electrograms (CFAE) Ablation Receives: Procedure: PVI+CFAE+DCC |
| CFAE + Lines | Active comparator | CFAE Ablation followed by linear lesions (anterior and Roof line) Receives: Procedure: PVI, CFAE, anterior and roof line, DCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmia
Documented freedom from atrial arrhythmia (AF or AT) recurrence
Measured: 12 months
Secondary outcomes (2)
Procedural and safety data
Duration of procedure, ablation time, fluoroscopy time and complications
Measured: 12 months
Number and result of reablation procedure
Number of redo procedures, results and type of recurrent arrhythmia
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 posted11 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionDec 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059369
- Sponsor's protocol ID
- GER-EP-013
- Acronym
- ADLINE
- Status last verified
- Apr 2017
- First submitted
- 23 May 2013
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02059369
- Acronym / sponsor ID
- ADLINE / GER-EP-013
- Conditions
- Atrial Fibrillation, Recurrence
- Keywords
- Atrial fibrillation, Recurrence, CFAE, linear ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Feb 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.
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFAE ablation | Active comparator | Procedure: PVI+CFAE+DCCIntervention: Complex fractionated atrial electrograms (CFAE) Ablation |
| CFAE + Lines | Active comparator | Procedure: PVI, CFAE, anterior and roof line, DCCCFAE Ablation followed by linear lesions (anterior and Roof line) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with symptomatic persistent AF
- After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia
Key exclusion criteria (1 listed)
- Left atrial thrombus
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 |
|---|---|---|
| PVI+CFAE+DCCpulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists | Procedure or surgery | CFAE ablation |
| PVI, CFAE, anterior and roof line, DCCPVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists | Procedure or surgery | CFAE + Lines |
Primary outcome
Freedom from atrial arrhythmia
Time frame: 12 months
Documented freedom from atrial arrhythmia (AF or AT) recurrence
2 secondary outcomes
Procedural and safety data
Time frame: 12 months
Number and result of reablation procedure
Time frame: 12 months
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 11 Apr 2017.
Related trials for Atrial Fibrillation
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
RecruitingObservational study
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
Atrial Fibrillation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI+CFAE+DCC and PVI, CFAE, anterior and roof line, DCC in people with Atrial Fibrillation and Recurrence, 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 2 inclusion and 1 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 11 Apr 2017. 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?
Freedom from atrial arrhythmia (time frame: 12 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 11 Apr 2017.