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Non-fluoroscopy Ablation of AF/AT

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03750435
Acronym
ZERO-AF
Enrollment
25
Registered
2018-11-23
Start date
2018-10-08
Completion date
2019-10-08
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AF - Atrial Fibrillation, Atrial Tachycardia

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.

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.

Interventions

PROCEDUREAF 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.

Sponsors

Baylis Medical Company
CollaboratorINDUSTRY
Royal Brompton & Harefield NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective single arm

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety of the zero AF procedure6 monthsAbsence 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
Feasibility and efficacy6 monthsAssessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up

Secondary

MeasureTime frameDescription
Recurrences6 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)

Countries

United Kingdom

Contacts

Primary ContactSabine Ernst, MD
s.ernst@rbht.nhs.uk02073518612
Backup ContactJenny Rivers
j.rivers@rbht.nhs.uk020 7352 8121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026