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

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03351816
• Collaborator: (none)
• Enrollment: 106
• Locations: 3
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site: 35.3
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Ablation of atrial fibrillation; Procedure: Cardioversion	N/A

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

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardioversion group Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.	Procedure: Cardioversion; External electric shock delivery under general anesthesia.
Experimental: Ablation group 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; Pulmonary vein isolation by radiofrequency or cryoablation.

Outcome Measures

Primary Outcome Measures

1. Recurrent atrial fibrillation [12 months]

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

2. Recurrent atrial tachycardia [12 months]

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

3. Recurrent flutter [12 months]

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

Secondary Outcome Measures

1. Recurrent atrial fibrillation [3 months]

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

2. Recurrent atrial tachycardia [3 months]

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

3. Recurrent flutter [3 months]

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

4. Palpitations [12 months]

   Any episode of palpitation occurring during follow-up

5. Hospitalization [12 months]

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

6. Repeat ablation [12 months]

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

7. Cardioversion [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Jean Minjoz	Besancon		France	25000
2	CHU François Mitterand	Dijon		France
3	CHU Brabois	Vandoeuvre les nancy		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

• Study Director: Nicolas Meneveau, MD, PhD, Centre Hospitalier Universitaire de Besancon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT03351816
• Other Study ID Numbers: 2017-A00731-52
• First Posted: Nov 24, 2017
• Last Update Posted: Dec 23, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Dec 23, 2020