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

Atrial Fibrillation Clinical Trial

— Biorhythm  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351816
• Other study ID #: 2017-A00731-52
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 1, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation of atrial fibrillation
Pulmonary vein isolation by radiofrequency or cryoablation.
• Cardioversion
External electric shock delivery under general anesthesia.

Locations

Country	Name	City	State
France	University Hospital Jean Minjoz	Besancon
France	CHU François Mitterand	Dijon
France	CHU Brabois	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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