- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03750435
Non-fluoroscopy Ablation of AF/AT (ZERO-AF)
ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sabine Ernst, MD
- Phone Number: 02073518612
- Email: s.ernst@rbht.nhs.uk
Study Contact Backup
- Name: Jenny Rivers
- Phone Number: 020 7352 8121
- Email: j.rivers@rbht.nhs.uk
Study Locations
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London, United Kingdom, SW3 6NP
- Recruiting
- Royal Brompton and Harefield NHS Foundation Trust
-
Contact:
- Jenny Rivers
- Phone Number: 020 7352 8121
- Email: j.rivers@rbht.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the zero AF procedure
Time Frame: 6 months
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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
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Feasibility and efficacy
Time Frame: 6 months
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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
|
|
6 months
|
Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMRBH01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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