Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
212 participants
INTERVENTIONAL
2021-11-30
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PVI only
Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.
Pulmonary veins isolation
Wide area circumferential pulmonary veins isolation
PVI + IM
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.
Pulmonary veins isolation + Cartofinder-guided ablation
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.
Interventions
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Pulmonary veins isolation + Cartofinder-guided ablation
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 isolation
Wide area circumferential pulmonary veins isolation
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent.
3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
4. In atrial fibrillation at the time of the index procedure.
Exclusion Criteria
2. Previous ablation procedure for atrial fibrillation.
3. Left ventricular ejection fraction \< 45%
4. Obesity with BMI \> 35 kg/m2
5. Congenital heart disease.
6. Previous cardiac surgery with atriotomy.
7. Previous left atrial appendage closure/ligation.
8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
9. Pregnancy
10. Current enrolment in a study evaluating another device or drug.
18 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Vias Markides, MD, FESC
Role: STUDY_DIRECTOR
Royal Brompton Hospital, London, UK
Central Contacts
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Other Identifiers
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297733
Identifier Type: -
Identifier Source: org_study_id
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