Atrial FibrillationPhase 2CAVERNNCT01432743
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
A Phase 2 study testing NavX Fusion and Cartomerge in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- NavX Fusion and Cartomerge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Apr 2011
- Phase
- Phase 2
- 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
- Be at least 18 years of age
- Be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of AF
- Be willing and able to sign the study specific informed consent
- Have a negative pregnancy test for female subjects of child bearing potential
Who cannot join
- Have a left ventricular ejection fraction (LVEF) of <40% as evaluated by pre-procedure TTE
- Have any contraindication or allergy to routine procedural medications or catheter materials
- Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (EP) catheterisation
- Be currently participating in another clinical research study
- Have any condition for which the subject's life expectancy is less than twelve months
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Integration of a previously acquired image of the left atrium into the electroanatomical (EA) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM, etc). Although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial
Read the detailed description
Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter ablation procedure and data is collected. Both systems are routinely used in our clinical practise. This is a comparison trial of 2 mapping technologies.
- Conditions
- Atrial Fibrillation
- Being tested
- NavX Fusion, Cartomerge
- Keywords
- 3D mapping, Image integration, Atrial fibrillation, 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.
NavX FusionProcedure or surgery
Also called NavX Fusion (St Jude) - electroanatomic mapping
Using NavX Fusion to guide catheter ablation
CartomergeProcedure or surgery
Also called Cartomerge (Biosense Webster) - electroanatomic mapping
Guidance of catheter ablation using Cartomerge guidance
| Study group | Role | What they receive |
|---|---|---|
| Cartomerge | Experimental | Use of Cartomerge to guide ablation Receives: Procedure: Cartomerge |
| NavX Fusion | Active comparator | Use of NavX fusion to guide ablation Receives: Procedure: NavX Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
Measured: 6 months
Secondary outcomes (2)
Lesion distance from CT shell
Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy
Measured: At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)
Procedural time points
Measurement of all procedural time points during procedure, along with x-ray dose and screening times.
Measured: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionApr 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Richard Schilling, Barts & The London NHS Trust
- Investigators
- Richard Schilling, FRCP, Principal investigator, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432743
- Sponsor's protocol ID
- 005126
- Acronym
- CAVERN
- Status last verified
- Sep 2011
- First submitted
- 21 Feb 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Finlay MC, Hunter RJ, Baker V, Richmond L, Goromonzi F, Thomas G, Rajappan K, Duncan E, Tayebjee M, Dhinoja M, Sporton S, Earley MJ, Schilling RJ. A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial. J Interv Card Electrophysiol. 2012 Mar;33(2):161-9. doi: 10.1007/s10840-011-9632-7. Epub 2011 Nov 26.
PubMed 22119854
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01432743
- Acronym / sponsor ID
- CAVERN / 005126
- Conditions
- Atrial Fibrillation
- Keywords
- 3D mapping, Image integration, Atrial fibrillation, Catheter Ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Sep 2011 (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.
Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Integration of a previously acquired image of the left atrium into the electroanatomical (EA) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM, etc). Although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial
Detailed description
Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter ablation procedure and data is collected. Both systems are routinely used in our clinical practise. This is a comparison trial of 2 mapping technologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cartomerge | Experimental | Procedure: CartomergeUse of Cartomerge to guide ablation |
| NavX Fusion | Active comparator | Procedure: NavX FusionUse of NavX fusion to guide ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age
- Be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of AF
- Be willing and able to sign the study specific informed consent
- Have a negative pregnancy test for female subjects of child bearing potential
Key exclusion criteria (5 listed)
- Have a left ventricular ejection fraction (LVEF) of <40% as evaluated by pre-procedure TTE
- Have any contraindication or allergy to routine procedural medications or catheter materials
- Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (EP) catheterisation
- Be currently participating in another clinical research study
- Have any condition for which the subject's life expectancy is less than twelve months
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 |
|---|---|---|
| NavX FusionAlso: NavX Fusion (St Jude) - electroanatomic mappingUsing NavX Fusion to guide catheter ablation | Procedure or surgery | NavX Fusion |
| CartomergeAlso: Cartomerge (Biosense Webster) - electroanatomic mappingGuidance of catheter ablation using Cartomerge guidance | Procedure or surgery | Cartomerge |
Primary outcome
AF recurrence
Time frame: 6 months
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
2 secondary outcomes
Lesion distance from CT shell
Time frame: At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)
Procedural time points
Time frame: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)
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 13 Sep 2011.
- Derived from this study: PubMed 22119854Finlay MC, Hunter RJ, Baker V, Richmond L, Goromonzi F, Thomas G, Rajappan K, Duncan E, Tayebjee M, Dhinoja M, Sporton S, Earley MJ, Schilling RJ. A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial. J Interv Card Electrophysiol. 2012 Mar;33(2):161-9. doi: 10.1007/s10840-011-9632-7. Epub 2011 Nov 26.
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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.
Richard Schilling, FRCP principal investigator
Barts and the London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NavX Fusion and Cartomerge in people with Atrial Fibrillation, run by Barts & The London NHS Trust 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 4 inclusion and 5 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 13 Sep 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AF recurrence (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 NCT01432743, 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 13 Sep 2011.