Persistent Atrial FibrillationIMAGE AFNCT05065112
Individualised Mapping in Persistent AF Ablation
A study testing Pulmonary veins isolation + Cartofinder-guided ablation and Pulmonary veins isolation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust.
Trial summary
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary veins isolation + Cartofinder-guided ablation and Pulmonary veins isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to May 2025
- 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
- Age > 18 years old
- Signed informed consent.
- Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
- In atrial fibrillation at the time of the index procedure.
Who cannot join
- Paroxysmal atrial fibrillation.
- Previous ablation procedure for atrial fibrillation.
- Left ventricular ejection fraction < 45%
- Obesity with BMI > 35 kg/m2
- Congenital heart disease.
- Previous cardiac surgery with atriotomy.
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- Previous left atrial appendage closure/ligation.
- Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
- Pregnancy
- Current enrolment in a study evaluating another device or drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary veins isolation + Cartofinder-guided ablation, Pulmonary veins isolation
- Keywords
- persistent atrial fibrillation, catheter ablation, individualized mapping, focal activity, rotational activity
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary veins isolation + Cartofinder-guided ablationProcedure or surgery
The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.
Pulmonary veins isolationProcedure or surgery
Wide area circumferential pulmonary veins isolation
| Study group | Role | What they receive |
|---|---|---|
| PVI only | Active comparator | Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF. Receives: Procedure: Pulmonary veins isolation |
| PVI + IM | Experimental | Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF. Receives: Procedure: Pulmonary veins isolation + Cartofinder-guided ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmia
Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs
Measured: 12 monts
Secondary outcomes (3)
Freedom from atrial fibrillation
Freedom from atrial fibrillation without the use of antiarrhythmic drugs
Measured: 12 months
Atrial fibrillation burden reduction
Reduction of the atrial fibrillation burden by 75% compared to baseline
Measured: 12 months
Absolute atrial fibrillation burden
Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.
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 posted1 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vias Markides, MD, FESC, Study director, Royal Brompton Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065112
- Sponsor's protocol ID
- 297733
- Acronym
- IMAGE AF
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05065112
- Acronym / sponsor ID
- IMAGE AF / 297733
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, catheter ablation, individualized mapping, focal activity, rotational activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Oct 2021 (actual)
- 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.
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI only | Active comparator | Procedure: Pulmonary veins isolationPatients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF. |
| PVI + IM | Experimental | Procedure: Pulmonary veins isolation + Cartofinder-guided ablationPatients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Signed informed consent.
- Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
- In atrial fibrillation at the time of the index procedure.
Key exclusion criteria (10 listed)
- Paroxysmal atrial fibrillation.
- Previous ablation procedure for atrial fibrillation.
- Left ventricular ejection fraction < 45%
- Obesity with BMI > 35 kg/m2
- Congenital heart disease.
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 |
|---|---|---|
| Pulmonary veins isolation + Cartofinder-guided ablationThe individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier. | Procedure or surgery | PVI + IM |
| Pulmonary veins isolationWide area circumferential pulmonary veins isolation | Procedure or surgery | PVI only |
Primary outcome
Freedom from atrial arrhythmia
Time frame: 12 monts
Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs
3 secondary outcomes
Freedom from atrial fibrillation
Time frame: 12 months
Atrial fibrillation burden reduction
Time frame: 12 months
Absolute atrial fibrillation burden
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Vias Markides, MD, FESC study director
Royal Brompton Hospital, London, UK
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary veins isolation + Cartofinder-guided ablation and Pulmonary veins isolation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust.
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 10 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 1 Oct 2021. 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 Vias Markides, MD, FESC (020 7352 8121, v.markides@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial arrhythmia (time frame: 12 monts). 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 1 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.