Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832206
• Other study ID #: PRAGUE-21
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: December 10, 2019

Study information

• Verified date: August 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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)

Locations

Country	Name	City	State
Czechia	Charles University, Third Faculty of Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QoL measurement	changes in quality of life, measured by questionnaires AFEQT	1 year
Primary	sinus rhythm (The Reveal LINQ Insertable Cardiac Monitoring System)	Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)	1 year
Secondary	neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler)	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
Secondary	periprocedural complications - surgery	conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia	30 days