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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ablation of atrial fibrillation
Cardioversion
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Jean Minjoz
  • CHU François Mitterand
  • CHU Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cardioversion group

Ablation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrent atrial fibrillation
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent atrial tachycardia
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent flutter
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2017
Last Updated
December 22, 2020
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03351816
Brief Title
Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
Acronym
Biorhythm
Official Title
Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardioversion group
Arm Type
Experimental
Arm Description
Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.
Arm Title
Ablation group
Arm Type
Experimental
Arm Description
Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.
Intervention Type
Procedure
Intervention Name(s)
Ablation of atrial fibrillation
Intervention Description
Pulmonary vein isolation by radiofrequency or cryoablation.
Intervention Type
Procedure
Intervention Name(s)
Cardioversion
Intervention Description
External electric shock delivery under general anesthesia.
Primary Outcome Measure Information:
Title
Recurrent atrial fibrillation
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
12 months
Title
Recurrent atrial tachycardia
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
12 months
Title
Recurrent flutter
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Recurrent atrial fibrillation
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
3 months
Title
Recurrent atrial tachycardia
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
3 months
Title
Recurrent flutter
Description
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Time Frame
3 months
Title
Palpitations
Description
Any episode of palpitation occurring during follow-up
Time Frame
12 months
Title
Hospitalization
Description
Hospital admission related to atrial fibrillation, atrial tachycardia or flutter during follow-up
Time Frame
12 months
Title
Repeat ablation
Description
Need for repeat ablation during follow-up in patients who underwent ablation of AF
Time Frame
12 months
Title
Cardioversion
Description
Need for electric or medical cardioversion during follow-up (all patients, regardless of initial intervention type)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Meneveau, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU François Mitterand
City
Dijon
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre les nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34187182
Citation
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.
Results Reference
derived

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

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