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Hybrid Atrial Fibrillation Ablation Registry

Identification of a Risk Profile Associated With Failure of the Hybrid Ablation of Atrial Fibrillation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02516033
Enrollment
250
Registered
2015-08-05
Start date
2015-01-01
Completion date
2026-05-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

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

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.

Detailed description

Rationale: 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. Objective: To determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure in patients with atrial fibrillation. Study design: A prospective single center registry. Study population: Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants. Intervention: Extra study related procedures include blood sampling for biomarkers and genetic analysis at baseline and 1 year follow-up; prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/ atrial flutter/atrial tachycardias at 3 months, 6 months and 1 year follow-up; and a quality of life questionnaire at baseline, and at 1 year and 5 year follow-up. Total follow-up duration: Five years. Main study endpoints: 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.

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Failure of the hybrid ablation procedure in patients with atrial fibrillation1 yearAny (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \>30sec without anti-arrhythmic drugs at 1 year by ECG recording and 3-day Holter monitoring.

Contacts

PRINCIPAL_INVESTIGATORIsabelle C Van gelder, MD, PhD

University Medical Center Groningen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026