Wall thickness in the upper chamber of the heart and its effect on heart rhythm disorders

Not Applicable

Completed

• Conditions: Atrial fibrillation; Circulatory System

• Registration Number: ISRCTN10910054
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

2021 Results article in https://doi.org/10.3389/fcvm.2021.655252 (added 09/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Study Completion: 2018-04-01
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Cases:
1. Between the ages of 18 and 75
2. Capable of giving informed, written consent in English
3. Planned for a first clinically indicated ablation procedure for atrial fibrillation/tachycardia
4. Planned for AF/AT ablation under general anaesthetic

Controls:
1. Between the ages of 18 and 75
2. Capable of giving informed, written consent in English
3. Have a clinical indication for cardiac CT (CCT)
4. No history of AF

Exclusion Criteria

1. Patient is not able or willing to provide written, informed consent in English
2. Patient does not meet all of the inclusion criteria
3. Patient is enrolled in another clinical trial that involves an extension of the duration of the AF ablation procedure
4. Patient has a contraindication to adequate cardiovascular computed tomography imaging including but not limited to body habitus, implanted material and iodine based contrast allergy
5. Patient has a contraindication to adequate cardiac magnetic resonance imaging including but not limited to body habitus, implanted material, claustrophobia and gadolinium based contrast allergy
6. Patient has chronic kidney disease stage with an estimated glomerular filtration rate of below 50ml/min (in whom there is greater conferring an additional risk of developing contrast induced nephropathy following CCT and CMR imaging)
7. Patient has an implantable cardiac electrical device
8. Patient is female and of childbearing potential (to reduce the excess risk associated with radiation exposure in this group)
9. Patient has any of the following comorbidities:
9.1. Moderate or severe valvular stenosis or regurgitation
9.2. Hypertension of more than 10 years duration, or not adequately controlled with 2 or fewer anti-hypertensive agents
9.3. Left ventricular hypertrophy with maximum LV wall thickness greater than 15mm
9.4. Hypertrophic cardiomyopathy
9.5. Left ventricular failure with ejection fraction less than 40%

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Tissue thickness in the left atrium in patients and controls is measured using cardiac computed tomography (CCT) at baseline<br> 2. Firbosis and sphericity in patients and controls is measured using cardiac magenetic resonance (CMR) at baseline<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Recurrence of rhythm disturbance within patients is measured using ambulatory ECG monitoring at 12 months as part of routine clinical care<br> 2. Tissue characteristics of patients with recurrence and those without recurrence of AF in the patient group are measured using cardiac magenetic resonance (CMR) at baseline<br>