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

Not Applicable

• Conditions: Atrial Fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619001172190
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint<br>The primary endpoints will be lambda-f/lambda-d (rate constants of phase singularity (PS) formation and destruction).<br><br>Phase singularity detection will be performed with an extended topological charge based approach. A look up table indexing onset and offset times and electrode location for each new PS detection will be created to determine PS lifetime and PS inter-formation event times. Using the look up table, computation of the histograms for PS lifetimes and inter-formation event times will be performed. For each epoch, observed PS lifetime data will be fitted with an exponential distribution using maximum likelihood and the PS formation rate, lambda-f and destruction rate, lambda-d determined.[lambda-f/lambda-d (rate constants of PS formation and destruction) will be determined from intra-procedurally acquired HD grid data.]

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint 1 will be cholinergic modulation of lambda-d/lambda-f as assessed by edrophonium challenge; <br><br>The association of cholinergic and sympathetic modulation with lambda-f/lambda-d, will be assessed using a linear mixed effects model with repeated measures. [The secondary endpoint will be assessed in post-hoc analysis after the ablation procedure.];Secondary endpoint 2 will be sympathetic modulation of lambda-d/lambda-f as after isoproterenol administration.[Will be performed in post-hoc analysis after the ablation procedure]