Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation

Study Overview
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Brief Summary
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The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2) measured pre-procedure for the prediction of procedural success in patients with atrial fibrillation undergoing cardioversion or ablation.

Detailed Description
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This is a prospective, observational, multicentre study of patients with paroxystic or persistent atrial fibrillation scheduled to undergo cardioversion or ablation of AF in routine practice. Serum levels of MR proANP and ST2 pre-procedure will be measured to attempt to identify a threshold that carries prognostic value for procedural success (maintenance of sinus rhythm at one year).

Official Title
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Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation of atrial fibrillation
* Procedure: Cardioversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with paroxystic or persistent atrial fibrillation for whom a decision to perform ablation is made. Patients with persistent atrial fibrillation for whom a decision to perform cardioversion is made. Patients with social security coverage, or beneficiary thereof. Patients who provide written informed consent. Exclusion Criteria: Age <18 years or >80 years Patients with significant valvular heart disease defined as symptomatic aortic valve disease, severe aortic or mitral stenosis or tricuspid or mitral insufficiency grade 3/4 or 4/4 Patients with pulmonary arterial hypertension >45 mmHg on echocardiography Patients with chronic respiratory disease, chronic obstructive pulmonary disease stage II, III or IV. Patients with a left ventricular ejection fraction <45% Patients with recent (<1 month) acute decompensation of heart failure Patients with recent (<1 month) acute coronary syndrome Anemia (hemoglobin <10 g/dL) Pregnant or lactating women Patients with anticipated poor compliance, as assessed by the study investigator Patients within the exclusion period of another clinical study Patients under legal guardianship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioversion group<br>Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care. | Procedure: Cardioversion<br>* External electric shock delivery under general anesthesia.<br>|
| Experimental: Ablation group<br>Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care. | Procedure: Ablation of atrial fibrillation<br>* Pulmonary vein isolation by radiofrequency or cryoablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent atrial fibrillation | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 12 months | 
| Recurrent atrial tachycardia | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 12 months | 
| Recurrent flutter | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent atrial fibrillation | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 3 months | 
| Recurrent atrial tachycardia | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 3 months | 
| Recurrent flutter | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. | 3 months | 
| Palpitations | Any episode of palpitation occurring during follow-up | 12 months | 
| Hospitalization | Hospital admission related to atrial fibrillation, atrial tachycardia or flutter during follow-up | 12 months | 
| Repeat ablation | Need for repeat ablation during follow-up in patients who underwent ablation of AF | 12 months | 
| Cardioversion | Need for electric or medical cardioversion during follow-up (all patients, regardless of initial intervention type) | 12 months |