Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) (CE-AF)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Serge A. Trines, Leiden University
ClinicalTrials.gov Identifier:
NCT01361295
First received: May 20, 2011
Last updated: April 3, 2015
Last verified: April 2015
  Purpose

Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.

Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.

The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.

Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.


Condition Intervention
Atrial Fibrillation
Procedure: PVI with PVAC gold
Procedure: PVI with Cooled-RF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Cerebral embolism [ Time Frame: Between 24 hours before the ablation and 24 hours after the ablation ] [ Designated as safety issue: Yes ]
    Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.


Secondary Outcome Measures:
  • Neuropsychological functioning [ Time Frame: Between a week before the ablation until 3 months after the ablation ] [ Designated as safety issue: Yes ]
    A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure

  • Rise in procoagulation [ Time Frame: Between 24 hours before the ablation and 24 hours after the ablation ] [ Designated as safety issue: Yes ]
    The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.


Estimated Enrollment: 70
Study Start Date: March 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PVI with PVAC gold
Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.
Procedure: PVI with Cooled-RF
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
Other Name: CARTO3 system
Active Comparator: PVI with Cooled-RF
Patient for pulmonal vein isolation using the Cooled-RF catheter.
Procedure: PVI with PVAC gold
Pulmonary vein isolation using the Medtronic PVAC gold catheter
Other Name: Medtronic AF solutions

Detailed Description:

A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.

Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.

Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.

Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suffering from drug-refractory paroxysmal atrial fibrillation
  • scheduled for first ablation procedure

Exclusion Criteria:

  • contra-indications for DW-MRI
  • previous AF-ablation
  • minors
  • any patient unable to undergo neuropsychological testing due to mental retardation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361295

Locations
Netherlands
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands
Sponsors and Collaborators
Serge A. Trines
Investigators
Principal Investigator: Serge A. Trines, MD, PhD Cardiology, LUMC
  More Information

Publications:
Responsible Party: Serge A. Trines, Senior cardiologist, Leiden University
ClinicalTrials.gov Identifier: NCT01361295     History of Changes
Other Study ID Numbers: CE-AF-002
Study First Received: May 20, 2011
Last Updated: April 3, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
Atrial fibrillation
cerebral embolism
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Intracranial Embolism
Arrhythmias, Cardiac
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Embolism and Thrombosis
Heart Diseases
Intracranial Embolism and Thrombosis
Nervous System Diseases
Pathologic Processes
Thromboembolism
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on August 30, 2015