Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

NCT03388333 | Completed

• 1 other identifier: D4/17-06
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of patients with short term reoccurrences of atrial fibrillation after ablation.

  Holter ECGs and ECGs after atrial fibrillation ablation

  3 months

Secondary Outcomes (1)

• Change in heart rate after pulmonary vein isolation

  3 days.

Study Arms (3)

Atrial fibrillation ablation group

Patients undergoing catheter ablation for the treatment of atrial fibrillation.

Procedure: Catheter Ablation

Electrophysiological study group

Patients undergoing a diagnostic electrophysiological study without ablation.

Atrial flutter ablation group

Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus.

Procedure: Catheter Ablation

Interventions

Catheter Ablation PROCEDURE

Atrial fibrillation ablation group; Atrial flutter ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation schedulded for pulmonary vein isolation

You may qualify if:

• patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon
• patients scheduled for an electrophysiological study without ablation
• patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter

You may not qualify if:

• patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Christian Meyer, Prof. Dr.

  Germany Department of Cardiology - Electrophysiology, University Heart Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Christian Meyer

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: April 1, 2019
• Last Updated: June 7, 2019

Record last verified: 2018-10

Locations

DE (1)