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

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation of atrial fibrillation; Procedure: Cardioversion

Study type: Interventional

Funder types: Other

Identifiers

NCT03351816

2017-A00731-52

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Cardioversion group

Experimental group

Description:

Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.

Treatment:

Procedure: Cardioversion

Ablation group

Experimental group

Description:

Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.

Treatment:

Procedure: Ablation of atrial fibrillation