Persistent Atrial FibrillationNCT05086861
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
A study testing Oesophageal pacing after left atrial posterior wall isolation in people with Persistent Atrial Fibrillation and Atrial Fibrillation Ablation, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Atrial Fibrillation Ablation
- What is being tested?
- Oesophageal pacing after left atrial posterior wall isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2016to 1 Oct 2020
- 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
- Unable or willing to give fully informed written consent
- Turned down for general anaesthetic
- Pregnancy
- Terminal illness
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.
Investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study
Read the detailed description
Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.
This would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.
- Being tested
- Oesophageal pacing after left atrial posterior wall isolation
- Keywords
- Oesophageal Pacing, Hybrid Ablation, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oesophageal pacing after left atrial posterior wall isolationDevice
Following AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall. entrance and exit block.
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal Pacing Arm | Experimental | Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation. Receives: Device: Oesophageal pacing after left atrial posterior wall isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial posterior wall isolation
Measured via invasive left atrial mapping
Measured: Through study completion, an average of 4 years
Secondary outcomes (2)
Complication rate
Documentation of the number of complications caused by the oesophageal pacing procedure
Measured: Through study completion, an average of 4 years
Feasibility of using device
The success rate of left atrial posterior wall isolation.
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start23 Mar 2016
- Primary completion1 Oct 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Haywood, MD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086861
- Sponsor's protocol ID
- 15/P/094
- Status last verified
- Dec 2020
- First submitted
- 29 Aug 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
- ClinicalTrials.gov ID
- NCT05086861
- Acronym / sponsor ID
- 15/P/094
- Keywords
- Oesophageal Pacing, Hybrid Ablation, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 21 Oct 2021 (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.
Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.
Investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study
Detailed description
Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.
This would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oesophageal Pacing Arm | Experimental | Device: Oesophageal pacing after left atrial posterior wall isolationPatients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation. |
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 (5 listed)
- Unable or willing to give fully informed written consent
- Turned down for general anaesthetic
- Pregnancy
- Terminal illness
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.
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 |
|---|---|---|
| Oesophageal pacing after left atrial posterior wall isolationFollowing AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall. entrance and exit block. | Device | Oesophageal Pacing Arm |
Primary outcome
Left atrial posterior wall isolation
Time frame: Through study completion, an average of 4 years
Measured via invasive left atrial mapping
2 secondary outcomes
Complication rate
Time frame: Through study completion, an average of 4 years
Feasibility of using device
Time frame: Through study completion, an average of 4 years
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 21 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Guy Haywood, MD principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oesophageal pacing after left atrial posterior wall isolation in people with Persistent Atrial Fibrillation and Atrial Fibrillation Ablation, run by University Hospital Plymouth 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 5 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 21 Oct 2021. 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?
Left atrial posterior wall isolation (time frame: Through study completion, an average of 4 years). 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 21 Oct 2021.