AF - Atrial FibrillationZERO-AFNCT03750435
Non-fluoroscopy Ablation of AF/AT
A study testing AF ablation or left-sided AT ablation in people with AF - Atrial Fibrillation and Atrial Tachycardia, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- AF - Atrial Fibrillation, Atrial Tachycardia
- What is being tested?
- AF ablation or left-sided AT ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2018to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
Jenny Rivers, 020 7352 8121, j.rivers@rbht.nhs.uk
About this study
Official title: ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia
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.
Read the 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.
- Conditions
- AF - Atrial Fibrillation, Atrial Tachycardia
- Being tested
- AF ablation or left-sided AT ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablation or left-sided AT ablationProcedure or surgery
According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Ablation for AF or left-sided AT | Experimental | 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. Receives: Procedure: AF ablation or left-sided AT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Feasibility and efficacy
Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start8 Oct 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion8 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF - Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective single arm
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Baylis Medical Company
- Responsible party
- Sponsor
- Investigators
- Sabine Ernst, MD, Principal investigator, Royal Brompton and Harefield NHSSabine Ernst, MD, Study director, Royal Brompton and Harefield NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750435
- Sponsor's protocol ID
- BMRBH01
- Acronym
- ZERO-AF
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia
- ClinicalTrials.gov ID
- NCT03750435
- Acronym / sponsor ID
- ZERO-AF / BMRBH01
- Conditions
- AF - Atrial Fibrillation, Atrial Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Baylis Medical Company
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 8 Oct 2019 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective single arm
| Arm | Type | Receives |
|---|---|---|
| Ablation for AF or left-sided AT | Experimental | Procedure: AF ablation or left-sided AT ablationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any type of atrial fibrillation or left atrial tachycardia
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF ablation or left-sided AT ablationAccording to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed. | Procedure or surgery | Ablation for AF or left-sided AT |
Primary outcome
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
1 secondary outcome
Recurrences
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Individual participant dataSharing planned: Yes. Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Ernst, MD principal investigator
Royal Brompton and Harefield NHS
Sabine Ernst, MD study director
Royal Brompton and Harefield NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation or left-sided AT ablation in people with AF - Atrial Fibrillation and Atrial Tachycardia, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Ernst, MD (02073518612, s.ernst@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the zero AF procedure (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.