Atrial FibrillationPhase 4NCT00678340
Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
A Phase 4 study testing WACA and PVI and PVAC in people with Atrial Fibrillation, run by Pier Lambiase at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- WACA and PVI and PVAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal AF with a planned ablation procedure
Who cannot join
- Prior AF ablation
- LA size greater than 60mm
- Mechanical prosthetic MVR
- Hypertrophic cardiomyopathy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College Hospital London NHS Foundation Trust
London
About this study
Official title: A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
Read more
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
- Conditions
- Atrial Fibrillation
- Being tested
- WACA and PVI, PVAC
- Keywords
- Randomized Controlled Trial, Single-Blind Study, 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.
WACA and PVIDevice
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
PVACDevice
Also called Pulmonary vein ablation catheter, Ablation Frontiers
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | WACA and PVI Receives: Device: WACA and PVI |
| 2 | Active comparator | PVAC Receives: Device: PVAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Measured: 1 year
Procedural time for pulmonary vein isolation
Measured: Index procedure
Secondary outcomes (3)
All procedural complications
Measured: Index
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Measured: 6 months
Quality of life questionnaire
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2013
- Study completionMar 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pier Lambiase
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, The Royal Bournemouth Hospital
- Responsible party
- Sponsor-investigator, Pier Lambiase, University College London Hospitals
- Investigators
- Pier D Lambiase, PhD, Principal investigator, University College Hospital London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678340
- Sponsor's protocol ID
- UCH 07/0094
- Status last verified
- Mar 2013
- First submitted
- 14 Feb 2008
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.
PubMed 24843051
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00678340
- Acronym / sponsor ID
- UCH 07/0094
- Conditions
- Atrial Fibrillation
- Keywords
- Randomized Controlled Trial, Single-Blind Study, Catheter Ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Pier LambiaseUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, The Royal Bournemouth Hospital
- Study start
- Sep 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 May 2008 (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.
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: WACA and PVIWACA and PVI |
| 2 | Active comparator | Device: PVACPVAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with paroxysmal AF with a planned ablation procedure
Key exclusion criteria (4 listed)
- Prior AF ablation
- LA size greater than 60mm
- Mechanical prosthetic MVR
- Hypertrophic cardiomyopathy
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 |
|---|---|---|
| WACA and PVIWide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter. | Device | 1 |
| PVACAlso: Pulmonary vein ablation catheter, Ablation FrontiersCircumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence. | Device | 2 |
Primary outcome
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Time frame: 1 year
Procedural time for pulmonary vein isolation
Time frame: Index procedure
3 secondary outcomes
All procedural complications
Time frame: Index
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Time frame: 6 months
Quality of life questionnaire
Time frame: 6 months and 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 6 Mar 2013.
- Derived from this study: PubMed 24843051McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Pier D Lambiase, PhD principal investigator
University College Hospital London NHS Foundation Trust
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 WACA and PVI and PVAC in people with Atrial Fibrillation, run by Pier Lambiase at 1 site in United Kingdom.
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 1 inclusion and 4 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 6 Mar 2013. 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 United Kingdom. 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?
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 of AF at 1 year following AF ablation procedure measured by 7 day holter recording (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT00678340, 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 6 Mar 2013.