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

Status

Completed

Conditions

Intervention / Treatment

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

  • Czechia
      • Prague, Czechia, 10000
        • Charles university, Third Faculty of Medicine

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
hybrid ablation
60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation
Procedure: hybrid ablation
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sinus rhythm (The Reveal LINQ Insertable Cardiac Monitoring System)
Time Frame: 1 year
Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler)
Time Frame: 180 days
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
180 days
periprocedural complications - surgery
Time Frame: 30 days
conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL measurement
Time Frame: 1 year
changes in quality of life, measured by questionnaires AFEQT
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

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.

General Publications

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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