Atrial FibrillationTARGET-AF2NCT04633265
ECG-I Targeted Ablation for Persistent AF Not Responding to Pulmonary Vein Isolation Results of a Two Staged Strategy.
A study testing ECG-I Mapping of Atrial Fibrillation in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Atrial Fibrillation (AF) is a irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is a treatment where catheters are passed through the veins in the leg into the left atrium of the heart and lines of scar is delivered to disrupt tissue causing and maintaining atrial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECG-I Mapping of Atrial Fibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 31 Mar 2021
- 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
None listed.
Who cannot join
- Exclusions:
- Continuous persistent AF > 2 years duration
- Left atrial diameter > 5 cm
- Severe left ventricular impairment (EF < 40%)
- New York Heart Association class 3 or 4 heart failure
- Known hypertrophic cardiomyopathy, cardiac sarcoid or Arrhythmogenic Cardiomyopathy.
Show all 21Show fewer
- Known inherited arrhythmia such as Brugada or long QT syndromes
- Valvular disease that is more than moderate
- History of valve replacement (metallic or tissue)
- History of congenital heart disease (other than patent foramen ovale)
- Previous left atrial ablation (percutaneous or surgical)
- Cardiac surgery or percutaneous coronary intervention within the last 3 months.
- Myocardial infarction or unstable angina within the last 3 months.
- Unwillingness for ablation
- Unwillingness to be involved in study
- Suspected reversible cause of AF
- Any other contraindication to catheter ablation
- Age < 18 yrs or > 80 years
- Pregnancy
- Morbid obesity (defined as body mass index >40)
- Any other medical problem likely to cause death within the next 18 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECG-I Targeted Ablation for Persistent AF Not Responding to Pulmonary Vein Isolation: Results of a Two Staged Strategy (ECG-I TARGET AF2)
Atrial Fibrillation (AF) is a irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is a treatment where catheters are passed through the veins in the leg into the left atrium of the heart and lines of scar is delivered to disrupt tissue causing and maintaining atrial fibrillation. Current strategies involve isolating the pulmonary veins which have been shown to trigger and maintain AF. However, success rates for persistent AF lie in the region of 30-60% due to the drivers of AF residing elsewhere to the Pulmonary Veins antra.
The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.
Read more
Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically.
PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.
Read the detailed description
Atrial Fibrillation (AF) is the commonest heart rhythm disturbance and is associated with significant morbidity and mortality. Catheter ablation (CA) is a procedure where catheters (leads) are passed into the heart and energy is used to disrupt and isolate (by freezing or cauterising) heart tissue causing AF. CA is an established therapy for AF. Success rates for CA for paroxysmal AF lies in the region of 70% or better. However, success rates for persistent AF is much lower and estimates lie in the region of 30-60%.
Current CA protocols for AF centre on isolating the pulmonary veins (the pulmonary veins drain into the left atrium) which have been proven to trigger AF. Pulmonary Vein Isolation (PVI) ablation alone seems sufficient to remove the trigger for the vast majority of patients with paroxysmal AF. However, in patients with persistent AF it is common for AF to continue after the pulmonary veins have been electrically isolated.
The difference in success rates between the paroxysmal and persistent form of AF is thought to be due to changes within the heart atria after AF has been established for some time. In persistent AF the atria dilate and remodel structurally and electrically, and therefore the maintenance of persistent AF differs from paroxysmal AF.
Persistent AF is thought to be maintained by focal sources, whether rotors or sites of radial activation. Currently, targeting other sites within the atria in addition to PVI such as fractionated electrograms (areas of electrical activity) are thought to be imprecise and require extensive ablation. Often AF will persist despite targeting additional sites within the atria.
One particular challenge is to select patients likely to benefit from CA. CA carries an approximate less than 1% risk of life threatening complication. Therefore being able to select suitable patients is desirable in order to prevent unnecessary procedures.
Currently clinical characteristics of patients or structural imaging have limited accuracy in selecting patients likely to benefit from CA. Mapping studies have shown that patients with persistent AF who have higher frequency signals near the pulmonary veins than being distributed in the left atrial body are more likely to terminate to sinus rhythm (normal heart rhythm) with PVI alone and to maintain sinus rhythm.
Studies have suggested that patients undergoing standard PVI ablation procedures for persistent AF who have coincidental interruption of drivers have a far better long term outcome. This suggests that the characteristics of atrial heart tissue and electrical activation patterns maintaining AF are likely to determine the response to ablation therefore it may be possible to determine more directly and accurately the likelihood of success by performing non-invasive mapping of the atria using the ECG-I.
ECG-I is able to localise the drivers of AF and one of the objectives is to study the electrical characteristics of the tissue. ECG-I is currently being used in research into AF. A recently published a study using ECG-I to identify targets of ablation in 103 patients. The on-going multicentre AFACART study has published early data to suggest that ECG-I can identify the drivers of AF and improve CA success rates.
PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.
- Conditions
- Atrial Fibrillation
- Being tested
- ECG-I Mapping of Atrial Fibrillation
- Keywords
- Atrial Fibrillation ECG-I Mapping Catheter 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.
ECG-I Mapping of Atrial FibrillationDevice
Catheter ablation of Atrial Fibrillation guided by ECG-I
| Study group | Role | What they receive |
|---|---|---|
| ECG-I Mapping and Ablation of drivers | Experimental | ECG-I Mapping will be performed and drivers will be ablated as directed by ECG-I. Receives: Device: ECG-I Mapping of Atrial Fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants free from Atrial Arrhythmia at 12 months
Number of participants free from atrial arrhythmia (including both AF and atrial tachycardia) at 12 months following their procedure
Measured: 12 months
Secondary outcomes (2)
Rates of termination of AF with ECGI guided ablation
The proportion of patients in whom AF terminates with ablation during the catheter ablation procedure
Measured: Intra-procedural (day 1)
Number of participants free from AF at 12 months
Number of participants free from AF at 12 months following their procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start10 Jan 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633265
- Sponsor's protocol ID
- 218367-3
- Acronym
- TARGET-AF2
- Status last verified
- Oct 2024
- First submitted
- 10 Jul 2018
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG-I Targeted Ablation for Persistent AF Not Responding to Pulmonary Vein Isolation: Results of a Two Staged Strategy (ECG-I TARGET AF2)
- ClinicalTrials.gov ID
- NCT04633265
- Acronym / sponsor ID
- TARGET-AF2 / 218367-3
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation ECG-I Mapping Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 Nov 2020 (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 (AF) is a irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is a treatment where catheters are passed through the veins in the leg into the left atrium of the heart and lines of scar is delivered to disrupt tissue causing and maintaining atrial fibrillation. Current strategies involve isolating the pulmonary veins which have been shown to trigger and maintain AF. However, success rates for persistent AF lie in the region of 30-60% due to the drivers of AF residing elsewhere to the Pulmonary Veins antra.
The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.
Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically.
PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.
Detailed description
Atrial Fibrillation (AF) is the commonest heart rhythm disturbance and is associated with significant morbidity and mortality. Catheter ablation (CA) is a procedure where catheters (leads) are passed into the heart and energy is used to disrupt and isolate (by freezing or cauterising) heart tissue causing AF. CA is an established therapy for AF. Success rates for CA for paroxysmal AF lies in the region of 70% or better. However, success rates for persistent AF is much lower and estimates lie in the region of 30-60%.
Current CA protocols for AF centre on isolating the pulmonary veins (the pulmonary veins drain into the left atrium) which have been proven to trigger AF. Pulmonary Vein Isolation (PVI) ablation alone seems sufficient to remove the trigger for the vast majority of patients with paroxysmal AF. However, in patients with persistent AF it is common for AF to continue after the pulmonary veins have been electrically isolated.
The difference in success rates between the paroxysmal and persistent form of AF is thought to be due to changes within the heart atria after AF has been established for some time. In persistent AF the atria dilate and remodel structurally and electrically, and therefore the maintenance of persistent AF differs from paroxysmal AF.
Persistent AF is thought to be maintained by focal sources, whether rotors or sites of radial activation. Currently, targeting other sites within the atria in addition to PVI such as fractionated electrograms (areas of electrical activity) are thought to be imprecise and require extensive ablation. Often AF will persist despite targeting additional sites within the atria.
One particular challenge is to select patients likely to benefit from CA. CA carries an approximate less than 1% risk of life threatening complication. Therefore being able to select suitable patients is desirable in order to prevent unnecessary procedures.
Currently clinical characteristics of patients or structural imaging have limited accuracy in selecting patients likely to benefit from CA. Mapping studies have shown that patients with persistent AF who have higher frequency signals near the pulmonary veins than being distributed in the left atrial body are more likely to terminate to sinus rhythm (normal heart rhythm) with PVI alone and to maintain sinus rhythm.
Studies have suggested that patients undergoing standard PVI ablation procedures for persistent AF who have coincidental interruption of drivers have a far better long term outcome. This suggests that the characteristics of atrial heart tissue and electrical activation patterns maintaining AF are likely to determine the response to ablation therefore it may be possible to determine more directly and accurately the likelihood of success by performing non-invasive mapping of the atria using the ECG-I.
ECG-I is able to localise the drivers of AF and one of the objectives is to study the electrical characteristics of the tissue. ECG-I is currently being used in research into AF. A recently published a study using ECG-I to identify targets of ablation in 103 patients. The on-going multicentre AFACART study has published early data to suggest that ECG-I can identify the drivers of AF and improve CA success rates.
PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG-I Mapping and Ablation of drivers | Experimental | Device: ECG-I Mapping of Atrial FibrillationECG-I Mapping will be performed and drivers will be ablated as directed by ECG-I. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Exclusions:
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 |
|---|---|---|
| ECG-I Mapping of Atrial FibrillationCatheter ablation of Atrial Fibrillation guided by ECG-I | Device | ECG-I Mapping and Ablation of drivers |
Primary outcome
Number of Participants free from Atrial Arrhythmia at 12 months
Time frame: 12 months
Number of participants free from atrial arrhythmia (including both AF and atrial tachycardia) at 12 months following their procedure
2 secondary outcomes
Rates of termination of AF with ECGI guided ablation
Time frame: Intra-procedural (day 1)
Number of participants free from AF at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG-I Mapping of Atrial Fibrillation in people with Atrial Fibrillation, run by Barts & The London NHS 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 0 inclusion and 21 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: finished, as of the sponsor's last update on 22 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants free from Atrial Arrhythmia at 12 months (time frame: 12 months). 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 22 Oct 2024.