Atrial FibrillationBiorhythmNCT03351816
Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
A study testing Ablation of atrial fibrillation and Cardioversion in people with Atrial Fibrillation, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation of atrial fibrillation and Cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2017to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital Jean Minjoz
Besançon, 25000
CHU François Mitterand
Dijon
CHU Brabois
Vandœuvre-lès-Nancy
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation of atrial fibrillation, Cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of atrial fibrillationProcedure or surgery
Pulmonary vein isolation by radiofrequency or cryoablation.
CardioversionProcedure or surgery
External electric shock delivery under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Cardioversion group | Experimental | Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care. Receives: 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. Receives: Procedure: Ablation of atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent atrial fibrillation
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 12 months
Recurrent atrial tachycardia
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 12 months
Recurrent flutter
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 12 months
Secondary outcomes (7)
Recurrent atrial fibrillation
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 3 months
Recurrent atrial tachycardia
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 3 months
Recurrent flutter
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Measured: 3 months
Palpitations
Any episode of palpitation occurring during follow-up
Measured: 12 months
Hospitalization
Hospital admission related to atrial fibrillation, atrial tachycardia or flutter during follow-up
Measured: 12 months
Repeat ablation
Need for repeat ablation during follow-up in patients who underwent ablation of AF
Measured: 12 months
Cardioversion
Need for electric or medical cardioversion during follow-up (all patients, regardless of initial intervention type)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Dec 2017
- Primary completion31 Mar 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Meneveau, MD, PhD, Study director, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351816
- Sponsor's protocol ID
- 2017-A00731-52
- Acronym
- Biorhythm
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2017
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40883706Badoz 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.
PubMed 34187182
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03351816
- Acronym / sponsor ID
- Biorhythm / 2017-A00731-52
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioversion group | Experimental | Procedure: CardioversionPatients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care. |
| Ablation group | Experimental | Procedure: Ablation of atrial fibrillationPatients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation of atrial fibrillationPulmonary vein isolation by radiofrequency or cryoablation. | Procedure or surgery | Ablation group |
| CardioversionExternal electric shock delivery under general anesthesia. | Procedure or surgery | Cardioversion group |
Primary outcome
Recurrent atrial fibrillation
Time frame: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent atrial tachycardia
Time frame: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent flutter
Time frame: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
7 secondary outcomes
Recurrent atrial fibrillation
Time frame: 3 months
Recurrent atrial tachycardia
Time frame: 3 months
Recurrent flutter
Time frame: 3 months
Palpitations
Time frame: 12 months
Hospitalization
Time frame: 12 months
Repeat ablation
Time frame: 12 months
Cardioversion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 40883706Badoz 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.
- Derived from this study: PubMed 34187182Badoz 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Meneveau, MD, PhD study director
Centre Hospitalier Universitaire de Besancon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation of atrial fibrillation and Cardioversion in people with Atrial Fibrillation, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent atrial fibrillation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351816, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.