Persistent Atrial FibrillationAF-FAIR-MONTORNCT05406310
Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring
An observational study of Persistent Atrial Fibrillation, run by St. Louis University.
Trial summary
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalize the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Ablation Index-guided ablation and High-power, short-duration ablation using QDOT Micro catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Jun 2025
- 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
- Adult, Older adult
Study population: Persistent atrial fibrillation patients who are 18 years or older and are indicated for atrial fibrillation ablation and have no exclusion criteria as listed above.
Who may be able to join
- Aged over 18 years
- Persistent AF defined according to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, as AF episode that lasts longer than 7 days. (Calkins et al., 2017)
- Symptomatic despite drug treatment.
- Due to undergo AF ablation.
Who cannot join
- Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
- Previous catheter or surgical ablation procedure for AF
- Unwillingness or inability to complete the required follow-up arrangements
- Current pattern of paroxysmal AF
- Long standing persistent AF (continuous AF longer than 12 months before ablation)
- Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
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- Known infiltrative cardiomyopathy
- Known severe left ventricular systolic function (ejection fraction <35%)
- Pregnancy
About this study
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalize the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many patients (almost 1 in 2), some of these ablation lesions recover, and that leads to the recurrence of AF. Many of these patients then need a second procedure to deliver further ablation at these recovered areas.
Because of that problem, a software called Ablation Index has been developed to optimize the delivery of ablation lesions. The study aims to find out the effectiveness of the use of that Ablation Index in improving the ablation outcomes in patients with persistent AF. Also, the study will test the effectiveness of a new ablation approach using a catheter which is capable of delivering high-power during ablation and therefore requires shorter time for ablation. This will be achieved by following up patients who received ablation for 12 months to monitor their response to treatment in terms of freedom from AF.
Read more
This study will include patients with persistent AF which means AF episode(s) that last for longer than seven days. Patients participating in the study will undergo their ablation treatment either guided by ablation Index or delivered using high-power, short-duration (HPSD) ablation.
All participants will undergo implantation of a cardiac monitor, also knowns as loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months and 12 months after the ablation procedure.
All participants will undergo implantation of a cardiac monitor, also knowns as a loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months, and 12 months after the ablation procedure.
Read the detailed description
Single-center, prospective cohort study including patients with persistent AF (PeAF).
Primary Hypothesis:
Single AF ablation procedure that includes PVI achieved with point-by-point Wide Area Circumferential catheter ablation (WACA) either guided by Ablation Index (AI) targets or by HPSD ablation delivered using QDOT Micro catheter results in reduction in ATA as detected by insertable cardiac monitor (ICM).
Secondary hypotheses:
Single AF ablation procedure that includes PVI achieved with point-by-point WACA guided by Ablation Index targets has low incidence of adverse events and results in freedom from ATA, and improvement of AF symptoms and quality of life.
AF ablation procedures done by HPSD ablation delivered using QDOT Micro catheter will have shorter time and similar outcomes to procedures done using SmartTouch SF catheter guided by Ablation Index targets.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Ablation Index-guided ablation, High-power, short-duration ablation using QDOT Micro catheter
- Keywords
- Ablation, Ablation Index, Loop Recorder, Recurrence
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation Index-guided ablationDevice
Radiofrequency catheter ablation guided by Ablation Index software.
High-power, short-duration ablation using QDOT Micro catheterDevice
Radiofrequency catheter ablation guided by high-power, short-duration ablation using QDOT Micro catheter
| Study group | Role | What they receive |
|---|---|---|
| Ablation-Index guided ablation group | This is the prospective study group that will undergo persistent atrial fibrillation ablation guided by Ablation Index. Receives: Device: Ablation Index-guided ablation | |
| High-power, short-duration ablation Group | This is another prospective group of patients who will undergo persistent atrial fibrillation ablation by high-power, short-duration using QDOT Micro catheter. Receives: Device: High-power, short-duration ablation using QDOT Micro catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICM-detected ATA burden
ICM-detected ATA burden measured as percentage of time spent in ATA (i.e., hours of ATA/hours of monitoring X 100)
Measured: 12 months
Secondary outcomes (3)
The occurrence of ATA recurrence of 2 minutes or more
Measured: 12 month
QOL
QOL 6 and 12 months after initial ablation, as quantified by the validated AFEQT questionnaire.
Measured: 6 and 12 months after initial ablation
Major complication rates
Major complications include cardiac tamponade, stroke/TIA, myocardial infarction, phrenic nerve paralysis, oesophageal perforation/atrio-oesophageal fistula, major vascular complications, and death.
Measured: Within 60 days after a PVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 May 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Investigator left institution and did not transfer study to another institution or PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406310
- Sponsor's protocol ID
- 32462
- Acronym
- AF-FAIR-MONTOR
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
PubMed 30354288Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N, Morgan M, Ronayne C, Shaw M, Snowdon R, Gupta D. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Sep;28(9):1037-1047. doi: 10.1111/jce.13281. Epub 2017 Jul 26.
PubMed 28639728
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring
- ClinicalTrials.gov ID
- NCT05406310
- Acronym / sponsor ID
- AF-FAIR-MONTOR / 32462
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Ablation, Ablation Index, Loop Recorder, Recurrence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator left institution and did not transfer study to another institution or PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Jun 2022 (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 commonest condition affecting the rhythm of the heart. Tablets to try to normalize the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many patients (almost 1 in 2), some of these ablation lesions recover, and that leads to the recurrence of AF. Many of these patients then need a second procedure to deliver further ablation at these recovered areas.
Because of that problem, a software called Ablation Index has been developed to optimize the delivery of ablation lesions. The study aims to find out the effectiveness of the use of that Ablation Index in improving the ablation outcomes in patients with persistent AF. Also, the study will test the effectiveness of a new ablation approach using a catheter which is capable of delivering high-power during ablation and therefore requires shorter time for ablation. This will be achieved by following up patients who received ablation for 12 months to monitor their response to treatment in terms of freedom from AF.
This study will include patients with persistent AF which means AF episode(s) that last for longer than seven days. Patients participating in the study will undergo their ablation treatment either guided by ablation Index or delivered using high-power, short-duration (HPSD) ablation.
All participants will undergo implantation of a cardiac monitor, also knowns as loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months and 12 months after the ablation procedure.
All participants will undergo implantation of a cardiac monitor, also knowns as a loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months, and 12 months after the ablation procedure.
Detailed description
Single-center, prospective cohort study including patients with persistent AF (PeAF).
Primary Hypothesis:
Single AF ablation procedure that includes PVI achieved with point-by-point Wide Area Circumferential catheter ablation (WACA) either guided by Ablation Index (AI) targets or by HPSD ablation delivered using QDOT Micro catheter results in reduction in ATA as detected by insertable cardiac monitor (ICM).
Secondary hypotheses:
Single AF ablation procedure that includes PVI achieved with point-by-point WACA guided by Ablation Index targets has low incidence of adverse events and results in freedom from ATA, and improvement of AF symptoms and quality of life.
AF ablation procedures done by HPSD ablation delivered using QDOT Micro catheter will have shorter time and similar outcomes to procedures done using SmartTouch SF catheter guided by Ablation Index targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation-Index guided ablation group | – | Device: Ablation Index-guided ablationThis is the prospective study group that will undergo persistent atrial fibrillation ablation guided by Ablation Index. |
| High-power, short-duration ablation Group | – | Device: High-power, short-duration ablation using QDOT Micro catheterThis is another prospective group of patients who will undergo persistent atrial fibrillation ablation by high-power, short-duration using QDOT Micro catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Persistent atrial fibrillation patients who are 18 years or older and are indicated for atrial fibrillation ablation and have no exclusion criteria as listed above.
Key inclusion criteria (4 listed)
- Aged over 18 years
- Persistent AF defined according to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, as AF episode that lasts longer than 7 days. (Calkins et al., 2017)
- Symptomatic despite drug treatment.
- Due to undergo AF ablation.
Key exclusion criteria (9 listed)
- Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
- Previous catheter or surgical ablation procedure for AF
- Unwillingness or inability to complete the required follow-up arrangements
- Current pattern of paroxysmal AF
- Long standing persistent AF (continuous AF longer than 12 months before ablation)
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 |
|---|---|---|
| Ablation Index-guided ablationRadiofrequency catheter ablation guided by Ablation Index software. | Device | Ablation-Index guided ablation group |
| High-power, short-duration ablation using QDOT Micro catheterRadiofrequency catheter ablation guided by high-power, short-duration ablation using QDOT Micro catheter | Device | High-power, short-duration ablation Group |
Primary outcome
ICM-detected ATA burden
Time frame: 12 months
ICM-detected ATA burden measured as percentage of time spent in ATA (i.e., hours of ATA/hours of monitoring X 100)
3 secondary outcomes
The occurrence of ATA recurrence of 2 minutes or more
Time frame: 12 month
QOL
Time frame: 6 and 12 months after initial ablation
Major complication rates
Time frame: Within 60 days after a PVI procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 30354288Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
- Background: PubMed 28639728Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N, Morgan M, Ronayne C, Shaw M, Snowdon R, Gupta D. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Sep;28(9):1037-1047. doi: 10.1111/jce.13281. Epub 2017 Jul 26.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by St. Louis University.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
ICM-detected ATA burden (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406310, which also lists 2 linked publications.
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 15 Jul 2024.