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Protocol for a prospective cross-sectional, study using Poisson renewal theory to study rotor formation and destruction rates in atrial fibrillation: the RENEWAL-AF study

Protocol for a prospective cross-sectional, study using Poisson renewal theory to study rotor formation and destruction rates in atrial fibrillation: the RENEWAL-AF study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001172190
Enrollment
168
Registered
2019-08-20
Start date
2020-03-18
Completion date
2026-12-28
Last updated
2026-09-14

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

Conditions

None listed

Brief summary

Introduction Unstable functional re-entrant circuits known as rotors have been consistently observed in atrial fibrillation, and are mechanistically believed critical to the maintenance of the arrhythmia. Recently, using a Poisson renewal theory-based quantitative framework, we have demonstrated that rotor formation (lambda-f) and destruction rates (lambda-d) can be accurately measured using in vivo electrophysiologic data. RENEWAL-AF measures the electrical, structural heart changes associated with differences in lambda-d and lambda-f.

Interventions

RENEWAL AF is a prospective cross-sectional study at a tertiary hospital recruiting adult patients with paroxysmal or persistent atrial fibrillation (AF) undergoing clinically indicated catheter ablation. Patients will undergo intraprocedural electrophysiologic AF mapping, with lambda-f and lambda-d to be determined from 2-minute unipolar electrogram recordings acquired prior to ablation. The total duration of observation will be in a single AF EEP study procedure (usual duration 120 minutes).

RENEWAL AF is a prospective cross-sectional study at a tertiary hospital recruiting adult patients with paroxysmal or persistent atrial fibrillation (AF) undergoing clinically indicated catheter ablation. Patients will undergo intraprocedural electrophysiologic AF mapping, with lambda-f and lambda-d to be determined from 2-minute unipolar electrogram recordings acquired prior to ablation. The total duration of observation will be in a single AF EEP study procedure (usual duration 120 minutes). The primary objective will be to determine the association of lambda-f and lambda-d with clinical, electrical and structural markers of atrial fibrillation progression, measured by pre-ablation echocardiogram and cardiac magnetic resonance imaging (MRI). The secondary objective will be the association between lambda-f/lambda-d with sympathetic and cholinergic modulation using isoproterenol and edrophonium during AF ablation.

Sponsors

Flinders University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria will be patients referred for clinically indicated AF ablation at Flinders Medical Centre and any other participating sites. Clinical indication for AF ablation includes 1) symptomatic AF refractory or intolerant to at least one class 1 or class 3 antiarrhythmic medication 2) selected symptomatic patients with heart failure and/or reduced ejection fraction.

Exclusion criteria

Exclusion criteria includes 1) patients unwilling to provide consent 2) patients unable to undergo pre-procedural cardiac magnetic resonance imaging (CMRI) 3) presence of LA thrombus 4) LA diameter>5.5 cm 5) >2 previous ablations for AF 6) contraindications to anticoagulation therapy 7) uncontrolled hypertension 8) uncontrolled thyroid disease and 9) severe cardiac valvular disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026