NCT03351816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

November 20, 2017

Last Update Submit

December 22, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Recurrent atrial fibrillation

    3 months

  • Recurrent atrial tachycardia

    3 months

  • Recurrent flutter

    3 months

  • Palpitations

    12 months

  • Hospitalization

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Cardioversion group

EXPERIMENTAL

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

Procedure: Cardioversion

Ablation group

EXPERIMENTAL

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

Interventions

Ablation of atrial fibrillationPROCEDURE

Pulmonary vein isolation by radiofrequency or cryoablation.

Ablation group
CardioversionPROCEDURE

External electric shock delivery under general anesthesia.

Cardioversion group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 under legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Jean Minjoz

Besançon, 25000, France

Location

CHU François Mitterand

Dijon, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, France

Location

Related Publications (2)

  • Badoz M, Serzian G, Favoulet B, Sellal JM, De Chillou C, Laurent G, Ecarnot F, Bardonnet K, Seronde MF, Schiele F, Meneveau N. MR-proANP, sST2, BNP and sinus rhythm maintenance 1 year after electrical cardioversion for atrial fibrillation. BMC Cardiovasc Disord. 2025 Aug 29;25(1):640. doi: 10.1186/s12872-025-05052-5.

    PMID: 40883706DERIVED

  • 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.

    PMID: 34187182DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Nicolas Meneveau, MD, PhD

    Centre Hospitalier Universitaire de Besancon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

December 1, 2017

Primary Completion

March 31, 2019

Study Completion

June 1, 2020

Last Updated

December 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)