Non-fluoroscopy Ablation of AF/AT (ZERO-AF)
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|ClinicalTrials.gov Identifier: NCT03750435|
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|AF - Atrial Fibrillation Atrial Tachycardia||Procedure: AF ablation or left-sided AT ablation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective single arm|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Feasibility and efficacy [ Time Frame: 6 months ]Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up
- 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)
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
|Contact: Sabine Ernst, MDfirstname.lastname@example.org|
|Contact: Jenny Rivers||020 7352 email@example.com|
|Royal Brompton and Harefield NHS Foundation Trust||Recruiting|
|London, United Kingdom, SW3 6NP|
|Contact: Jenny Rivers 020 7352 8121 firstname.lastname@example.org|
|Principal Investigator:||Sabine Ernst, MD||Royal Brompton and Harefield NHS|
|Study Director:||Sabine Ernst, MD||Royal Brompton and Harefield NHS|