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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cardioversion; Procedure: Ablation of atrial fibrillation

• Registration Number: NCT03351816
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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).

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2017-12-01
• Primary Completion: 2019-03-31
• Study Completion: 2020-06-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardioversion group	Cardioversion	Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.
Ablation group	Ablation of atrial fibrillation	Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.

Primary Outcome Measures

Name	Time	Method
Recurrent flutter	12 months	Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
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.

Secondary Outcome Measures

Name	Time	Method
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
Recurrent flutter	3 months	Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
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.
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)

Trial Locations

Locations (3)

CHU François Mitterand; 🇫🇷 Dijon, France

CHU Brabois; 🇫🇷 Vandoeuvre les nancy, France

University Hospital Jean Minjoz; 🇫🇷 Besancon, France