Atrial FibrillationNCT02516033
Hybrid Atrial Fibrillation Ablation Registry
An observational study of Atrial Fibrillation, run by University Medical Center Groningen.
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.
- Conditions
- Atrial Fibrillation
- 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.
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.
- First posted5 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2026
- Study completionMay 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle C Van gelder, MD, PhD, Principal investigator, University Medical Center Groningen
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