Status:
WITHDRAWN
Inflammatory and Endothelial Function Response, and Arrhythmia Recurrence Following Catheter Ablation for Atrial Fibrillation
Lead Sponsor:
Karan Saraf
Collaborating Sponsors:
University of Manchester
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Current international guidelines recommend a three-month blanking period after pulmonary vein isolation (PVI) for atrial fibrillation (AF). Early recurrence of atrial tachyarrhythmia (ERAT; comprising...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age 18-75 years
- Paroxysmal AF or persistent AF of less than 6 months' duration
- Structurally normal heart on transthoracic echocardiogram other than mild left atrial dilatation (\<34ml/m2, indexed to body surface area)
- Due to undergo pulmonary vein isolation on clinical grounds
- Exclusion criteria
- Known genetic/inherited disorder that predisposes to atrial fibrillation, or Brugada syndrome
- Metabolic syndrome as defined by National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) criteria
- Obesity (BMI\>40)
- Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA oral anticoagulant (NOAC)
- Known atrial flutter
- Ischaemic heart disease documented by coronary or CT angiography, or confirmed history of myocardial infarction
- Current stage II or III hypertension (diastolic BP \>100mmHg, systolic BP\>160mmHg) confirmed on serial readings or ambulatory monitoring
- Diabetes mellitus other than diet controlled
- Previous catheter or surgical ablation procedure for AF
- Unwillingness or inability to complete the required follow-up arrangements
- Persistent AF \> 6 months' duration or permanent AF
- Prior prosthetic heart valve replacement or structural cardiac abnormality including moderate or severe heart valve disease
- Moderate or severe left atrial dilatation
- Known infiltrative cardiomyopathy
- Known left ventricular systolic dysfunction (ejection fraction \<45%)
- Pregnancy
- Co-morbidities known to be associated with an inflammatory response (eg. Rheumatoid arthritis)
- Unexplained baseline elevation of ESR or CRP above the normal lab reference ranges
- Additional ablation lesions beyond pulmonary vein isolation
Exclusion
Key Trial Info
Start Date :
January 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04269785
Start Date
January 30 2023
End Date
June 1 2024
Last Update
November 1 2023
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