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Completed

NCT Number: NCT02832206

Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charles University, Third Faculty of Medicine

Prague, 10000, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hybrid Ablation

Procedure

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. periprocedural complications - surgery

    Time frame: 30 days

    conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia

Other outcomes

  1. QoL measurement

    Time frame: 1 year

    changes in quality of life, measured by questionnaires AFEQT

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

EndoMaze HYBRID project-a Detailed Assessment of Efficacy and Safety of Hybrid Ablation of Persistent and Long-standing Persistent Atrial Fibrillation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2016
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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