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OpenTrials
Completed

NCT Number: NCT03351816

Impact of New Biomarkers on 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Jean Minjoz, Besançon, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation of atrial fibrillation

Procedure

Pulmonary vein isolation by radiofrequency or cryoablation.

Cardioversion

Procedure

External electric shock delivery under general anesthesia.

Primary outcomes

  1. Recurrent atrial fibrillation

    Time frame: 12 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

  2. Recurrent atrial tachycardia

    Time frame: 12 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

  3. Recurrent flutter

    Time frame: 12 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

Secondary outcomes

  1. Recurrent atrial fibrillation

    Time frame: 3 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

  2. Recurrent atrial tachycardia

    Time frame: 3 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

  3. Recurrent flutter

    Time frame: 3 months

    Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.

  4. Palpitations

    Time frame: 12 months

    Any episode of palpitation occurring during follow-up

  5. Hospitalization

    Time frame: 12 months

    Hospital admission related to atrial fibrillation, atrial tachycardia or flutter during follow-up

  6. Repeat ablation

    Time frame: 12 months

    Need for repeat ablation during follow-up in patients who underwent ablation of AF

  7. Cardioversion

    Time frame: 12 months

    Need for electric or medical cardioversion during follow-up (all patients, regardless of initial intervention type)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: Biorhythm

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2017
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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