NCT02832206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

June 29, 2016

Last Update Submit

August 2, 2021

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationHybrid ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler)

    180 days

  • periprocedural complications - surgery

    30 days

Other Outcomes (1)

  • QoL measurement

    1 year

Study Arms (1)

hybrid ablation

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

Procedure: hybrid ablation

Interventions

hybrid ablationPROCEDURE

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)

hybrid ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with symptomatic, drug-resistant, stand-alone, persistent or long-standing persistent atrial fibrillation

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University, Third Faculty of Medicine

Prague, 10000, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 29360987DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zbynek Straka, MD, PhD

    University Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 14, 2016

Study Start

March 1, 2016

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

CZ(1)