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Non-fluoroscopy Ablation of AF/AT (ZERO-AF)

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ClinicalTrials.gov Identifier: NCT03750435
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Baylis Medical Company
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure where specialized wires (so-called catheters) are inserted in the left upper heart chamber. This requires crossing the wall between the right and left atrium with a long needle (a so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo to check if the needle is in the right position. The investigators developed a method to do the TSP without x-rays using a specialized needle that can be also shown as a little icon on the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to track the location of the catheters in cath labs worldwide, but the position of the needle was not tracked yet. The investigators seek to demonstrate that these procedures can be carried out safely, successfully and in a reproducible fashion without any radiation by taking advantage of "faking" the isolated tip of the needle as a catheter on the 3D mapping system. The results will be compared with historic procedures done by the same operator in the years 2012-2017.

Condition or disease Intervention/treatment Phase
AF - Atrial Fibrillation Atrial Tachycardia Procedure: AF ablation or left-sided AT ablation Not Applicable

Detailed Description:

The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or left atrial tachycardia can be studied without the use of fluoroscopy which should result in a low or ZERO overall radiation exposure for the entire ablation procedure. The investigators will assess the feasibility, safety and efficacy of this new approach.

The patient will be admitted in hospital as for a standard procedure and discharged the next day. Before admission, the patient undergoes a CMR/CT scan (routine in our centre). To avoid total radiation CMR would be preferred, if possible.

The technique of the TSP and the use of the RF needle is commonly used worldwide. The ability to visualize the needle tip on the 3D electroanatomical mapping system facilitates the procedure. The additional visualization by TOE helps to assure that the fossa ovalis has been correctly identified.

After the TSP, the ablation procedure itself will be carried out as conventionally performed using the catheter visualization on the 3D mapping system.

An ECG and an echocardiogram are performed before discharge (as standard care).

At 3 months the patient comes for the first visit and has an ECG, a Holter and symptom questionnaire.

At 6 months, the patient has second visit which includes an ECG, a symptom questionnaire, a Holter and an echocardiogram.

If recurrences of any arrhythmia occur, the patient can be scheduled for a second ablation procedure without any restrictions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ablation for AF or left-sided AT
The patient will be admitted in hospital as for a standard ablation procedure and discharged the next day. The procedure will be carried out without using fluoroscopy and relying on the visualization of the electroanatomical mapping system.
Procedure: AF ablation or left-sided AT ablation
According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.




Primary Outcome Measures :
  1. Safety of the zero AF procedure [ Time Frame: 6 months ]

    Absence of acute adverse events due to the use of non-fluoroscopic AF ablation

    • Evidence of chronic adverse events due to the use of non-fluoroscopic catheter ablation during the 6 months F/U period


  2. Feasibility and efficacy [ Time Frame: 6 months ]
    Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up


Secondary Outcome Measures :
  1. Recurrences [ Time Frame: 6 months ]
    • Time to first recurrence of AF/flutter/tachycardia (>30 sec)
    • Freedom of AF on previously failed antiarrhythmic medication; time-dependant variable
    • AF/flutter/tachycardia (> 30 sec) burden at 6 months F/U; this will be modelled as a continuous variable (number of episodes recorded)



Information from the National Library of Medicine

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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:

  • Any type of atrial fibrillation or left atrial tachycardia

    • Able to give written informed consent
    • Age >18 years old and ≤ 80 years
    • Fulfill established clinical criteria for catheter ablation of atrial fibrillation (1)
    • No evidence of significant structural heart disease or congenital heart disease

Exclusion Criteria:

Intolerance or unwillingness to oral anticoagulation with Warfarin

  • Bleeding disorder
  • Contraindication to CT scan
  • Presence of intracardiac thrombus
  • Vascular disorder preventing access to femoral veins
  • Cardiac congenital abnormality
  • Severe, life threatening non-cardiac disease
  • Active malignant disease and recent (<5 years) malignant disease
  • Presence of ASD or PFO closure device
  • Unable or unwilling to comply with F/U requirements
  • Renal impairment
  • Pregnancy

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): NCT03750435


Contacts
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Contact: Sabine Ernst, MD 02073518612 s.ernst@rbht.nhs.uk
Contact: Jenny Rivers 020 7352 8121 j.rivers@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Contact: Jenny Rivers    020 7352 8121    j.rivers@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Baylis Medical Company
Investigators
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Principal Investigator: Sabine Ernst, MD Royal Brompton and Harefield NHS
Study Director: Sabine Ernst, MD Royal Brompton and Harefield NHS

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03750435     History of Changes
Other Study ID Numbers: BMRBH01
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease