Paroxysmal Atrial FibrillationCPVA-PAFNCT00556595
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
A study testing primary electrophysiological approach and primary anatomical approach in people with Paroxysmal Atrial Fibrillation, run by University Hospital, Bonn.
Trial summary
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- primary electrophysiological approach and primary anatomical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2008
- 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
- paroxysmal atrial fibrillation
- age over 18 years
Who cannot join
- persistent atrial fibrillation
- reversible cause of atrial fibrillation
- inability to comply with follow-up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- primary electrophysiological approach, primary anatomical approach
- Keywords
- atrial fibrillation, paroxysmal, symptomatic, drug-refractory
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary electrophysiological approachProcedure or surgery
primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
primary anatomical approachProcedure or surgery
primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | primary electrophysiological approach Receives: Procedure: primary electrophysiological approach |
| 2 | Active comparator | primary anatomical approach Receives: Procedure: primary anatomical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial tachyarrhythmias at 6-months follow-up
Measured: 6 months
Secondary outcomes (1)
Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
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 posted12 Nov 2007 (estimated)
- Study startNov 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Lars M Lickfett, MD, Principal investigator, University Hospital Bonn, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556595
- Sponsor's protocol ID
- CPVA-PAF
- Other IDs
- IRB 160/07
- Acronym
- CPVA-PAF
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
PubMed 14557355Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.
PubMed 17562956Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.
PubMed 15927974
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach
- ClinicalTrials.gov ID
- NCT00556595
- Acronym / sponsor ID
- CPVA-PAF / CPVA-PAF
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- atrial fibrillation, paroxysmal, symptomatic, drug-refractory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 12 Nov 2007 (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.
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: primary electrophysiological approachprimary electrophysiological approach |
| 2 | Active comparator | Procedure: primary anatomical approachprimary anatomical approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- paroxysmal atrial fibrillation
- age over 18 years
Key exclusion criteria (3 listed)
- persistent atrial fibrillation
- reversible cause of atrial fibrillation
- inability to comply with follow-up
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 |
|---|---|---|
| primary electrophysiological approachprimary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice | Procedure or surgery | 1 |
| primary anatomical approachprimary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps | Procedure or surgery | 2 |
Primary outcome
Freedom from atrial tachyarrhythmias at 6-months follow-up
Time frame: 6 months
1 secondary outcome
Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
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 12 Nov 2007.
- Background: PubMed 14557355Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
- Background: PubMed 17562956Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.
- Background: PubMed 15927974Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.
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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.
Lars M Lickfett, MD principal investigator
University Hospital Bonn, Department of Cardiology
Questions about this trial
What is this clinical trial studying?
A study testing primary electrophysiological approach and primary anatomical approach in people with Paroxysmal Atrial Fibrillation, run by University Hospital, Bonn.
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 3 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 12 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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 Lars M Lickfett, MD (*49-228-287-16670, lars.lickfett@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial tachyarrhythmias at 6-months follow-up (time frame: 6 months). 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 NCT00556595, which also lists 3 linked publications.
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 Nov 2007.