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Characterising Left Atrial Function and Compliance in Atrial Fibrillation

The Impact of Left Atrial Function and Compliance in patients with paroxysmal and persistent Atrial Fibrillation undergoing Catheter Ablation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000639921
Enrollment
115
Registered
2020-06-01
Start date
2020-06-01
Completion date
2022-12-31
Last updated
2022-09-05

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

Conditions

None listed

Brief summary

This study will investigate the association between left atrial compliance on AF type (paroxysmal versus persistent), patient symptoms, exercise tolerance, left ventricular function and long-term prognosis. The hypothesis is that left atrial compliance will be increased in patients with persistent AF compared with those with paroxysmal AF and may be correlated with patient symptoms, exercise tolerance and long-term outcomes of AF ablation. This will be the first study to assess left atrial compliance using direct measurements of the left atrial dimensions and pressure and direct infusion of saline into the left atrium.

Interventions

All patients recruited to the study will have symptomatic atrial fibrillation (AF) planned for AF ablation. AF ablation is an interventional treatment for AF recommended for patients with symptomatic AF refractory to at least 1 anti-arrhythmic drug. Participants will be recruited when both patient and physician have decided to proceed with AF ablation. These patients will undergo AF ablation regardless of recruitment to the study. Within 4 weeks prior to their AF ablation, enrolled participants

All patients recruited to the study will have symptomatic atrial fibrillation (AF) planned for AF ablation. AF ablation is an interventional treatment for AF recommended for patients with symptomatic AF refractory to at least 1 anti-arrhythmic drug. Participants will be recruited when both patient and physician have decided to proceed with AF ablation. These patients will undergo AF ablation regardless of recruitment to the study. Within 4 weeks prior to their AF ablation, enrolled participants will undergo a series of non-invasive testing including baseline echocardiogram, stress echocardiogram, cardiopulmonary exercise testing and blood sampling for NT-pro BNP. They will also complete an AF symptom questionnaire and the Minnesota Living with Heart Failure questionnaire. AF ablation will then be undertaken as per standard institutional protocols. LA pressure will be measured via trans-septal puncture, as occurs routinely during such procedures. LA dimensions will be measured by transoesopageal echocardiography (TOE). TOE is also part of the standard procedure to exclude left atrial thrombus and guide transeptal puncture. Following baseline assessment of LA dimensions and LA pressure, the LA will be directly infused with isotonic saline through the standard LA sheath. The volume to be infused will be 15 mL/kg of body weight over 8 minutes. LA volume via TTE and LA pressure will be recorded every 2 minutes during the infusion using TTE. During infusion, LA pressure and respiratory parameters will be measured and infusion will be stopped if there is any evidence of fluid overload. LA compliance will be calculated from the LA volume pressure curve provided by these measurements. Procedure duration will be variable depending on the ablation procedure itself and can last anywhere between 1-4 hours. The study protocol will add only 10 minutes to the overall procedure. Following the procedure, patients will be followed up for a period of 12 months and in addition to standard follow-up protocols, will undergo repeat stress echocardiogram and CPET and 6 and 12 months post-procedure.

Sponsors

University of Adelaide
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

Symptomatic AF with scheduled AF ablation procedure and failed >1 antiarrhythmic drug therapy Capable of providing written consent Ability to perform an exercise stress test on a cycle ergometer

Exclusion criteria

Ejection fraction <50% by transthoracic echocardiography (TTE) determined by Simpsons biplane method at the time of enrolment Previous diagnosis of a cardiopmyopathy Moderate to severe valvulopathy Prior diagnosis of pulmonary hypertension Active malignancy Musculoskeletal diseases or injuries limiting exercise capacity Severe chronic obstructive pulmonary disease Moderate to severe valvulopathy Unable to provide written consent Unable to exercise

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026