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

NCT ID: NCT02832206

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2019-12-10

Brief 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.

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

hybrid ablation

60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation

hybrid ablation

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Petr Budera

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zbynek Straka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Kralovske Vinohrady

Locations

Charles University, Third Faculty of Medicine

Prague, , Czechia

Countries

Czechia

References

Osmancik P, Budera P, Zdarska J, Herman D, Petr R, Fojt R, Straka Z. Residual echocardiographic and computed tomography findings after thoracoscopic occlusion of the left atrial appendage using the AtriClip PRO device. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):919-925. doi: 10.1093/icvts/ivx427.

Reference Type: DERIVED

PMID: 29360987 (View on PubMed)

Other Identifiers

PRAGUE-21

Identifier Type: -

Identifier Source: org_study_id