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Biatrial global high-density electroanatomical mapping of atrial fibrillation – a prospective mechanistic registry study

Biatrial global high-density electroanatomical mapping of atrial fibrillation – a prospective mechanistic registry study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13986854
Enrollment
22
Registered
2018-09-28
Start date
2018-10-11
Completion date
Unknown
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System

Interventions

This is a prospective non-randomised registry study with a mechanistic and feasibility focus. This design was chosen as the primary objective is not to evaluate the effect of targeted atrial endocardi

Sponsors

Oxford University Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged 18 years or above 3. Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure 4. In the Investigator’s opinion is able and willing to comply with all trial requirements

Exclusion criteria

Exclusion criteria: 1. Physical or anatomical barriers to the use of two simultaneous mapping catheters 2. Previous cardiac surgery 3. Previous ablation (catheter or surgical) 4. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 6. Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks. (Involvement in any other research trial is not a contraindication per se)

Design outcomes

Primary

MeasureTime frame
Presence and number of pre-defined electrophysiological phenomena such as “rotors” and “focal firing”; Timepoint(s): during ablation procedure

Secondary

MeasureTime frame
1. Freedom from recurrent atrial fibrillation, defined as that seen on 12-lead ECG recording or >30 seconds on ambulatory monitoring at 12 months 2. Difference in conduction velocity, measured as a single vector and average vector in each atrial segment at longest and shortest cycle length and 3 vectors during catheter ablation procedure

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026