Atrial TachycardiaNCT06335446
Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation
An observational study of Atrial Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Tachycardia
- What is being tested?
- Novel mapping algorithm
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Oct 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AT (whether de novo or occurring post AF ablation) undergoing catheter ablation.
Who may be able to join
- Patients able to provide informed consent
- Patients with AT (whether de novo or occurring post AF ablation)
Who cannot join
- Unwillingness to sign consent
- Age <18 years old
- Contraindications for catheter ablation procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation (STAR Mapping)
Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.
STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT.
Read the detailed description
AT is a heart rhythm that currently can be effectively mapped and ablated using existing mapping systems. The mechanism of this heart rhythm is well understood.
Patients that are scheduled for a catheter ablation for AT by their Electrophysiologist will be enrolled into the study. The patient will have the procedure under local anaesthetics/sedation or general anaesthetic depending on their clinical need.
During the procedure tubes will be passed into the left upper chamber of the heart through the groin. Through these tubes catheters will be used to create a geometry of the heart chamber. Following this, in half of the patients a basket catheter with 64 electrodes will be positioned in the upper chamber whilst conventional catheters will be used in the other half of the patients. The aim of this is to demonstrate that the STAR mapping can be used with multiple mapping catheters. Signals i.e. electrograms will then be collected and used with the STAR mapping algorithm. The AT will then be effectively mapped and ablated with a conventional mapping system. The STAR mapping will then be used for post processing after the case to map the AT and will be compared to the maps generated by the conventional system. This will enable validation of the STAR mapping system.
- Conditions
- Atrial Tachycardia
- Being tested
- Novel mapping algorithm
- Keywords
- Atrial tachycardia, Electrogram, Ablation, Drivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel mapping algorithmOther
Also called STAR MAPPING
Signals will be collected during the catheter ablation. These signals STAR maps will be created post procedure and these will be compared to the conventional maps used during the atrial tachycardia ablation. This will be used to validate the STAR maps created.
| Study group | Role | What they receive |
|---|---|---|
| Atrial tachycardia- validation phase | The group will consist of patients with AT (whether de novo or occurring post AF ablation) that are undergoing catheter ablation. Receives: Other: Novel mapping algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAR maps compared to conventional maps
The STAR maps demonstrating the source of the AT correlate with the maps created by the conventional mapping system.
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startOct 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial TachycardiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT06335446
- Sponsor's protocol ID
- 011040- AT validation phase
- Other IDs
- PG/16/10/32016
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2018
- Last updated
- 28 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation (STAR Mapping)
- ClinicalTrials.gov ID
- NCT06335446
- Acronym / sponsor ID
- 011040- AT validation phase
- Conditions
- Atrial Tachycardia
- Keywords
- Atrial tachycardia, Electrogram, Ablation, Drivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 28 Mar 2024 (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 the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.
STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT.
Detailed description
AT is a heart rhythm that currently can be effectively mapped and ablated using existing mapping systems. The mechanism of this heart rhythm is well understood.
Patients that are scheduled for a catheter ablation for AT by their Electrophysiologist will be enrolled into the study. The patient will have the procedure under local anaesthetics/sedation or general anaesthetic depending on their clinical need.
During the procedure tubes will be passed into the left upper chamber of the heart through the groin. Through these tubes catheters will be used to create a geometry of the heart chamber. Following this, in half of the patients a basket catheter with 64 electrodes will be positioned in the upper chamber whilst conventional catheters will be used in the other half of the patients. The aim of this is to demonstrate that the STAR mapping can be used with multiple mapping catheters. Signals i.e. electrograms will then be collected and used with the STAR mapping algorithm. The AT will then be effectively mapped and ablated with a conventional mapping system. The STAR mapping will then be used for post processing after the case to map the AT and will be compared to the maps generated by the conventional system. This will enable validation of the STAR mapping system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial tachycardia- validation phase | – | Other: Novel mapping algorithmThe group will consist of patients with AT (whether de novo or occurring post AF ablation) that are undergoing catheter ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AT (whether de novo or occurring post AF ablation) undergoing catheter ablation.
Key inclusion criteria (2 listed)
- Patients able to provide informed consent
- Patients with AT (whether de novo or occurring post AF ablation)
Key exclusion criteria (3 listed)
- Unwillingness to sign consent
- Age <18 years old
- Contraindications for catheter ablation procedure
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 |
|---|---|---|
| Novel mapping algorithmAlso: STAR MAPPINGSignals will be collected during the catheter ablation. These signals STAR maps will be created post procedure and these will be compared to the conventional maps used during the atrial tachycardia ablation. This will be used to validate the STAR maps created. | Other | Atrial tachycardia- validation phase |
Primary outcome
STAR maps compared to conventional maps
Time frame: At procedure
The STAR maps demonstrating the source of the AT correlate with the maps created by the conventional mapping system.
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 28 Mar 2024.
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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?
An observational study of Atrial Tachycardia, 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 2 inclusion and 3 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 28 Mar 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?
STAR maps compared to conventional maps (time frame: At procedure). 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 28 Mar 2024.