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Atrial FibrillationNCT02516033

Hybrid Atrial Fibrillation Ablation Registry

An observational study of Atrial Fibrillation, run by University Medical Center Groningen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Fibrillation
How many people
250 participants
Where
No sites listed yet
Study dates
Jan 2015to May 2026
How long will I take part?
5 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None.

About this study

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

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.

Read the 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.

Keywords
Atrial Fibrillation, Hybrid Ablation, Efficacy, Risk Profile, Biomarkers
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionMay 2026
  4. Study completionMay 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
250 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516033
Sponsor's protocol ID
METc2014/239
Status last verified
May 2026
First submitted
3 Aug 2015
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40828897

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