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

ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton and Harefield NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Sabine Ernst, MD, Royal Brompton and Harefield NHS
  • Study Director: Sabine Ernst, MD, Royal Brompton and Harefield NHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

October 8, 2019

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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