Non-fluoroscopy Ablation of AF/AT

Atrial Tachycardia Clinical Trial

— ZERO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750435
• Other study ID #: BMRBH01
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: November 2018
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Sabine Ernst, MD
• Phone: 02073518612
• Email: s.ernst[@]rbht.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 8, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• AF - Atrial Fibrillation
• Atrial Fibrillation
• Atrial Tachycardia
• Tachycardia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Baylis Medical Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the zero AF procedure	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
Primary	Feasibility and efficacy	Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up	6 months
Secondary	Recurrences	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