Clinical trial NCT03351816: Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
Official title: Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent atrial fibrillation
timeFrame: 12 months
measure: Recurrent atrial tachycardia
timeFrame: 12 months
measure: Recurrent flutter
timeFrame: 12 months
Secondary outcomes:
measure: Recurrent atrial fibrillation
timeFrame: 3 months
measure: Recurrent atrial tachycardia
timeFrame: 3 months
measure: Recurrent flutter
timeFrame: 3 months
measure: Palpitations
timeFrame: 12 months
measure: Hospitalization
timeFrame: 12 months
measure: Repeat ablation
timeFrame: 12 months
measure: Cardioversion
timeFrame: 12 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital Jean Minjoz
city: Dijon
country: France
facility: CHU François Mitterand
city: Vandoeuvre les nancy
country: France
facility: CHU Brabois
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Nicolas Meneveau, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Badoz M, Serzian G, Favoulet B, Sellal JM, De Chillou C, Hammache N, Laurent G, Mebazaa A, Ecarnot F, Bardonnet K, Seronde MF, Schiele F, Meneveau N. Impact of Midregional N-Terminal Pro-Atrial Natriuretic Peptide and Soluble Suppression of Tumorigenicity 2 Levels on Heart Rhythm in Patients Treated With Catheter Ablation for Atrial Fibrillation: The Biorhythm Study. J Am Heart Assoc. 2021 Jul 6;10(13):e020917. doi: 10.1161/JAHA.121.020917. Epub 2021 Jun 30.