Atrial Fibrillation
Conditions
Brief summary
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
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).
Interventions
PROCEDUREAblation of atrial fibrillation
Pulmonary vein isolation by radiofrequency or cryoablation.
PROCEDURECardioversion
External electric shock delivery under general anesthesia.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent atrial fibrillation | 12 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
| Recurrent atrial tachycardia | 12 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
| Recurrent flutter | 12 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent atrial fibrillation | 3 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
| Recurrent atrial tachycardia | 3 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
| Recurrent flutter | 3 months | Documented by ECG, Holter, telemetry, and lasting 30 seconds or more. |
| Palpitations | 12 months | Any episode of palpitation occurring during follow-up |
| Hospitalization | 12 months | Hospital admission related to atrial fibrillation, atrial tachycardia or flutter during follow-up |
| Repeat ablation | 12 months | Need for repeat ablation during follow-up in patients who underwent ablation of AF |
| Cardioversion | 12 months | Need for electric or medical cardioversion during follow-up (all patients, regardless of initial intervention type) |
Countries
France
Outcome results
None listed