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CLOSE Versus High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466358
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Matevz Jan, University Medical Centre Ljubljana

Brief Summary:
The aim of this study is to compare two methods of catheter ablation for treatment of paroxysmal atrial fibrillation (AF). The first method being a modified CLOSE protocol used for the control group and the second high density mapping guided isolation of pulmonary veins used for the interventional group. Comparison will be made according to clinical parameters and also durability of pulmonary vein isolation.

Condition or disease Intervention/treatment Phase
Pulmonary Vein Isolation Procedure: Modified CLOSE protocol Procedure: High density mapping guided pulmonary vein isolation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of CLOSE Guided and High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified CLOSE protocol
Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol, confirmed with multipolar circular mapping catheter.
Procedure: Modified CLOSE protocol
Modified CLOSE protocol guided isolation of pulmonary veins.

Active Comparator: High density mapping guided pulmonary vein isolation
Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol and confirmed with high density mapping of each pulmonary vein antrum, with additional ablation lesions at sites of gap or dormant conduction.
Procedure: High density mapping guided pulmonary vein isolation
Modified CLOSE protocol guided isolation of pulmonary veins with additional ablations at sites of gaps or dormant conduction as evidenced by high density mapping of pulmonary vein antra.




Primary Outcome Measures :
  1. Recurrence of atrial fibrillation [ Time Frame: 3-12 months ]
    Atrial fibrillation recorded with 12-lead ECG, event monitor or a 30 seconds episode recorded with Holter ECG.

  2. Durability of pulmonary vein isolation [ Time Frame: 12 months ]
    Presence of gaps in the circumferential ablation line (reconduction of pulmonary veins) as evidenced at predefined remapping procedure.


Secondary Outcome Measures :
  1. Characteristics of gaps in ablation lines [ Time Frame: 0-12 months ]
    Characteristics of electrograms and ablation lesions in the areas where gaps in the ablation line will be discovered acutely during high density mapping at index procedure. Also, characteristics of electrograms and ablation lesions in the areas where gaps will be discovered at a remote re-mapping procedure at 12 months after the index procedure


Other Outcome Measures:
  1. Adverse events [ Time Frame: 0-1 month ]

    During and after the procedure and at clinical follow-ups, any serious adverse event will be recorded. Significant adverse events will be defined as all events that endanger the participant's health or prolong hospitalization, or require intervention:

    • Death in hospital
    • Pericardial effusion resulting in tamponade
    • Cerebral insult
    • Pneumonia
    • Phrenic nerve injury
    • Esophageal perforation
    • Cardiac arrest
    • Complete atrioventricular block
    • Vascular intervention and / or surgery
    • Transfusion



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • electrocardiographic evidence of paroxysmal AF in the last six months,
  • unsuccessful treatment with antiarrhythmic drugs or highly symptomatic arrhythmia episodes (EHRA 3 and 4).

Exclusion Criteria:

  • age over 80 years,
  • greatly enlarged left atrium (ultrasound parasternal diameter more than 50 mm),
  • life expectancy less than one year,
  • acute life-threatening disease,
  • previous heart surgery,
  • severe left or right ventricular dysfunction (LVEF equal or less than 35 %),
  • severe valve failure,
  • presence of a clot in the left atrium,
  • previous atrial fibrillation ablation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466358


Contacts
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Contact: Matevz Jan, MD 0038615228238 matevz.jan@kclj.si
Contact: Nina Kajdic, MD nina.kajdic@gmail.com

Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Study Director: Jernej Stublar, MSE University Medical Centre Ljubljana
Study Chair: Bor Antolic, MD, PhD University Medical Centre Ljubljana
Publications:

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Responsible Party: Matevz Jan, Principal investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04466358    
Other Study ID Numbers: CLOSEVSHD
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matevz Jan, University Medical Centre Ljubljana:
pulmonary vein isolation
paroxysmal atrial fibrillation
high density mapping
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes