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

NCT ID: NCT03351816

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-06-01

Brief Summary

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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

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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).

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cardioversion group

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

Group Type EXPERIMENTAL

Cardioversion

Intervention Type PROCEDURE

External electric shock delivery under general anesthesia.

Ablation group

Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.

Group Type EXPERIMENTAL

Ablation of atrial fibrillation

Intervention Type PROCEDURE

Pulmonary vein isolation by radiofrequency or cryoablation.

Interventions

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Ablation of atrial fibrillation

Pulmonary vein isolation by radiofrequency or cryoablation.

Intervention Type PROCEDURE

Cardioversion

External electric shock delivery under general anesthesia.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Meneveau, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Besancon

Locations

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University Hospital Jean Minjoz

Besançon, , France

Site Status

CHU François Mitterand

Dijon, , France

Site Status

CHU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40883706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34187182 (View on PubMed)

Other Identifiers

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2017-A00731-52

Identifier Type: -

Identifier Source: org_study_id