Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation
August 2, 2021 updated by: Petr Budera, Charles University, Czech Republic
EndoMaze HYBRID project-a Detailed Assessment of Efficacy and Safety of Hybrid Ablation of Persistent and Long-standing Persistent Atrial Fibrillation
This study evaluates in detail efficacy and safety (including neurological safety) of hybrid ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF).
An implantable ECG monitor will be implanted to all patients for rhythm monitoring.
Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.
Study Overview
Detailed Description
Hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial ablation) represent a new treatment option for patients with atrial fibrillation.
60 patients will undergo a two-stage, hybrid ablation, all of them will have an ECG monitoring device implanted and will be followed for up to three years. Neurological safety of both surgical and catheter procedures will be assessed by three examinations. Magnetic resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to search for (subclinical) cerebral ischemia. Complex neuropsychological examination will be performed before surgery, afer 1 month after surgery and at 180 days visit to search for changes in cognitive functions, behavioral functions etc. Transcranial Doppler will be performed during surgical and catheter ablation to detect microembolic signals.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czechia, 10000
- Charles university, Third Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with symptomatic, drug-resistant, stand-alone, persistent or long-standing persistent atrial fibrillation
Description
Inclusion Criteria:
- Patients age > 18 years
- Patients with persistent/long-standing persistent AF according to the standard EHRA definition.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
- Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
- Ability to sign an informed consent
Exclusion Criteria:
- Paroxysmal AF
- AF secondary to a reversible cause (i.e., thyreopathy, etc.)
- Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
- Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
- Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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hybrid ablation
60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation
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Surgical thoracoscopic epicardial ablation (box-lesion) and left atrial appendage occlusion , followed (after 2-3months) by electrophysiological examination, and catheter ablation (completion of the box-lesion, cavotricuspid isthmus ablation and other ablation if indicated)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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sinus rhythm (The Reveal LINQ Insertable Cardiac Monitoring System)
Time Frame: 1 year
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Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler)
Time Frame: 180 days
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new ischaemic brain lesions on MR performed at the discharge from surgery and at the 180 days visit), neuropsychological changes measured by special questionnaires, that will be filled at 30 and 180 days visit, periprocedural Doppler - hits rates on periprocedural transcranial Doppler measurement during both surgery and catheter ablation
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180 days
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periprocedural complications - surgery
Time Frame: 30 days
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conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia
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30 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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QoL measurement
Time Frame: 1 year
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changes in quality of life, measured by questionnaires AFEQT
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zbynek Straka, MD, PhD, University Hospital Kralovske Vinohrady
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
December 10, 2019
Study Completion (Actual)
December 10, 2019
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
July 11, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRAGUE-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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