Atrial Fibrillation RecurrentNCT04968678
Exploring P-Wave Duration in Arrhythmia Recurrence in Patients Undergoing AF Ablation
An observational study of Atrial Fibrillation Recurrent, run by Nik Spinthakis at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate whether P-wave duration in a baseline surface 12-lead ECGs correlates with recurrence of AF recurrence post successful ablation at the time of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- P-wave duration measurement on 12 lead ECG with standard parameters
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2021to 13 May 2023
- How long will I take part?
- 24 Months
- 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: This is a prospective single centre study of the investigators current registry of patients undergoing AF ablation from existing clinical procedural database which contains a record of all cryoablation performed within the hospital. All records once obtained from the main database, will then be uploaded into a password protected Excel spreadsheet and anonymised at the time of entry by the ICI.
Who may be able to join
- Patients with persistent, long persistent or paroxysmal AF undergone AF cryoablation from 2016 onwards
- Age >18
- Patient does not meet exclusion criteria -
Who cannot join
- Patients whose records cannot be obtained
- Patients with persistent, long persistent or paroxysmal AF undergone AF ablation prior to 2016
- Patients with no documented ECG in sinus rhythm prior to ablation
- Patients not undergoing cryoablation for AF -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Univeristy Hospital Plymouth
Plymouth, Devon, PL68DH
Guy Haywood, 07785955893, guyhaywood@nhs.net
Chris Rollinson, 07870636429, CROLLINSON@NHS.NET
About this study
Official title: Exploring the Relationship Between Duration of the Amplified P-Wave Arrhythmia and Recurrence in Patients With Persistent, Long Persistent or Paroxysmal AF Undergoing Cryoablation
The aim of this study is to investigate whether P-wave duration in a baseline surface 12-lead ECGs correlates with recurrence of AF recurrence post successful ablation at the time of the procedure.
Read the detailed description
Patients with paroxysmal AF are often treated arrhythmia-free (75%) with a single catheter ablation at 12 months post procedure . In contrast, in patients with persistent AF or long persistent AF, catheter ablation is more complex and often yields in lower success rates of around 50% often requiring multiple attempts .
The success rates remain low despite several different ablation sites having been proposed (additional lines plus PVI, epicardial approach).
There is growing evidence that PWD is associated with the extent of left atrial scarring and this can be used a potential predictor of AF recurrence . Moreover, results from the investigators group has previously shown that PWD correlated with the duration of the AF and this could be altered by extensive ablation .
It is uncertain whether PWD prior to any procedure for persistent AF, long persistent or paroxysmal AF can accurately predict failure of procedure.
This is a single centre observational study of persistent, long persistent and paroxysmal AF population who have undergo AF cryoablation in University Hospital Plymouth . All patients receive this current procedure as standard of care.
This study does not involve any patient contact out of the standard routine clinical follow up and therefore no public involvement has been sought.
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- P-wave duration measurement on 12 lead ECG with standard parameters
- Keywords
- P-wave duration, AF, cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-wave duration measurement on 12 lead ECG with standard parametersDiagnostic test
Hospital records will be used in order to obtain baseline characteristics and the most recent 12-lead ECG in sinus rhythm prior to ablation will be used to calculate PWD. Measurement of the PWD will be obtained at standard surface ECG recording settings of 25mm/s and 10mm/mV and measured accordingly to our previous protocol. In brief, all ECGs obtained will subsequently be anonymised and randomised by an Independent Clinical Investigator (ICI) before measured by the main clinical investigators blinded to initial results. If a dispute of the measurements arouse, consensus will be used to resolve it after consulting the Chief Investigator (CI) blinded to the results. Bland-Altman plots to minimise bias will be used
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation.
Primary.This will be documented in a 12 lead ECG >30sec post ablation according to standard operation procedures follow up. Patients are actively followed up in regular intervals (4-12-24 months) post procedure and are able to contact department for advise if clinically suspected recurrence of atrial fibrillation. This is well studied and documented in previous studies as an outcome of measure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start13 May 2021
- Primary completion13 Jan 2022 (estimated)
- Study completion13 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrentStudies 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
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Nik Spinthakis
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Guy Haywood
- Responsible party
- Sponsor-investigator, Nik Spinthakis, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968678
- Sponsor's protocol ID
- IRAS 287263-Local21/CAR/492
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To comply with the Data Protection legislation information must be collected and used fairly, stored safely and not disclosed to any unauthorised person. This applies to both manual and electronically held data. The Chief Investigator will preserve the confidentiality of participants taking part in the study and ensure the EU General Data Protection Regulation (GDPR) in conjunction with the UK Data Protection Act 2018, which sets out the statutory requirements for the processing of personal data, is adhered to. Study documents will be anonymised by allocation of a study number, and will not contain personal identifiable data. Finalised data in an anonymised electronic format will be sent via encrypted USB devices in order to be analysed in a password protected computer. For each patient, a study number will be allocated, and data entered on an anonymised electronic CRF (case report form) in the way of an excel spreadsheet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Duration of the Amplified P-Wave Arrhythmia and Recurrence in Patients With Persistent, Long Persistent or Paroxysmal AF Undergoing Cryoablation
- ClinicalTrials.gov ID
- NCT04968678
- Acronym / sponsor ID
- IRAS 287263-Local21/CAR/492
- Conditions
- Atrial Fibrillation Recurrent
- Keywords
- P-wave duration, AF, cryoablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nik SpinthakisUniversity, hospital or other
- Collaborators
- Dr Guy Haywood
- Study start
- 13 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (estimated)
- Study completion
- 13 May 2023 (estimated)
- First posted
- 20 Jul 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.
The aim of this study is to investigate whether P-wave duration in a baseline surface 12-lead ECGs correlates with recurrence of AF recurrence post successful ablation at the time of the procedure.
Detailed description
Patients with paroxysmal AF are often treated arrhythmia-free (75%) with a single catheter ablation at 12 months post procedure . In contrast, in patients with persistent AF or long persistent AF, catheter ablation is more complex and often yields in lower success rates of around 50% often requiring multiple attempts .
The success rates remain low despite several different ablation sites having been proposed (additional lines plus PVI, epicardial approach).
There is growing evidence that PWD is associated with the extent of left atrial scarring and this can be used a potential predictor of AF recurrence . Moreover, results from the investigators group has previously shown that PWD correlated with the duration of the AF and this could be altered by extensive ablation .
It is uncertain whether PWD prior to any procedure for persistent AF, long persistent or paroxysmal AF can accurately predict failure of procedure.
This is a single centre observational study of persistent, long persistent and paroxysmal AF population who have undergo AF cryoablation in University Hospital Plymouth . All patients receive this current procedure as standard of care.
This study does not involve any patient contact out of the standard routine clinical follow up and therefore no public involvement has been sought.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective single centre study of the investigators current registry of patients undergoing AF ablation from existing clinical procedural database which contains a record of all cryoablation performed within the hospital. All records once obtained from the main database, will then be uploaded into a password protected Excel spreadsheet and anonymised at the time of entry by the ICI.
Key inclusion criteria (3 listed)
- Patients with persistent, long persistent or paroxysmal AF undergone AF cryoablation from 2016 onwards
- Age >18
- Patient does not meet exclusion criteria -
Key exclusion criteria (4 listed)
- Patients whose records cannot be obtained
- Patients with persistent, long persistent or paroxysmal AF undergone AF ablation prior to 2016
- Patients with no documented ECG in sinus rhythm prior to ablation
- Patients not undergoing cryoablation for AF -
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 |
|---|---|---|
| P-wave duration measurement on 12 lead ECG with standard parametersHospital records will be used in order to obtain baseline characteristics and the most recent 12-lead ECG in sinus rhythm prior to ablation will be used to calculate PWD. Measurement of the PWD will be obtained at standard surface ECG recording settings of 25mm/s and 10mm/mV and measured accordingly to our previous protocol. In brief, all ECGs obtained will subsequently be anonymised and randomised by an Independent Clinical Investigator (ICI) before measured by the main clinical investigators blinded to initial results. If a dispute of the measurements arouse, consensus will be used to resolve it after consulting the Chief Investigator (CI) blinded to the results. Bland-Altman plots to minimise bias will be used | Diagnostic test | – |
Primary outcome
Recurrence of atrial fibrillation.
Time frame: 24 months
Primary.This will be documented in a 12 lead ECG >30sec post ablation according to standard operation procedures follow up. Patients are actively followed up in regular intervals (4-12-24 months) post procedure and are able to contact department for advise if clinically suspected recurrence of atrial fibrillation. This is well studied and documented in previous studies as an outcome of measure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Undecided. To comply with the Data Protection legislation information must be collected and used fairly, stored safely and not disclosed to any unauthorised person. This applies to both manual and electronically held data. The Chief Investigator will preserve the confidentiality of participants taking part in the study and ensure the EU General Data Protection Regulation (GDPR) in conjunction with the UK Data Protection Act 2018, which sets out the statutory requirements for the processing of personal data, is adhered to. Study documents will be anonymised by allocation of a study number, and will not contain personal identifiable data. Finalised data in an anonymised electronic format will be sent via encrypted USB devices in order to be analysed in a password protected computer. For each patient, a study number will be allocated, and data entered on an anonymised electronic CRF (case report form) in the way of an excel spreadsheet.
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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.
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 Fibrillation Recurrent, run by Nik Spinthakis 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 3 inclusion and 4 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 20 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Haywood, MBBD,MD (07785955893, guyhaywood@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation. (time frame: 24 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 20 Jul 2021.