Hybrid Atrial Fibrillation Ablation Registry

NCT02516033 | Completed DMC

• 1 other identifier: METc2014/239
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recently a combined approach of surgeon ablation in combination with endocardial ablation (hybrid ablation) has been introduced. This therapy has shown excellent results in patients with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in patients with persistent atrial fibrillation. The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure, in a prospective single center registry setting. The investigators evaluate all consecutive patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants. Extra study related procedures include blood sampling for biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life questionnaire. Total follow-up will be five years. Main study endpoint is failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \>30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Hybrid Ablation; Efficacy; Risk Profile; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Failure of the hybrid ablation procedure in patients with atrial fibrillation

  Any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \>30sec without anti-arrhythmic drugs at 1 year by ECG recording and 3-day Holter monitoring.

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.

You may qualify if:

• Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.

You may not qualify if:

• None.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (1)

• Velt MJH, Magni FT, Blaauw Y, Mariani MA, Klinkenberg TJ, Rienstra M, Mulder BA. Hybrid Atrial Fibrillation Ablation: Association of Clinical Characteristics, Biomarkers, and Blanking Period with Recurrence. Interdiscip Cardiovasc Thorac Surg. 2025 Sep 1;40(9):ivaf197. doi: 10.1093/icvts/ivaf197.

  PMID: 40828897 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Full blood sample

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabelle C Van gelder, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05