Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT03750435
Status:
UNKNOWN
Last Update Posted:
2018-11-26
First Post:
2018-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-fluoroscopy Ablation of AF/AT
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Organization:
Study Overview
Official Title:
ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZERO-AF
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: