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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Cardioversion; Procedure: Ablation of atrial fibrillation

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • University Hospital Jean Minjoz
  • Dijon, France
    • CHU François Mitterand
  • Vandoeuvre les nancy, France
    • CHU Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioversion group; Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.	Procedure: Cardioversion; External electric shock delivery under general anesthesia.
Experimental: Ablation group; Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.	Procedure: Ablation of atrial fibrillation; Pulmonary vein isolation by radiofrequency or cryoablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent atrial fibrillation	Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.	12 months
Recurrent atrial tachycardia	Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.	12 months
Recurrent flutter	Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Study Director: Nicolas Meneveau, MD, PhD, Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2017-A00731-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No