Paroxysmal Atrial FibrillationNCT04022954
HD Mapping of Atrial Fibrillation in Asia Pacific
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Abbott Medical Devices at 15 sites in 5 countries.
Trial summary
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 11 Sep 2019to 13 Aug 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations
Who may be able to join
- Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
- Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
- Subject is diagnosed with AF as defined by:
- Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
- Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
- Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
- Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation
Who cannot join
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
- Participation in another clinical investigation that may confound the results of this study
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 months
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Japan8 sites
Yokosuka Kyosai Hospital
Kanagawa
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8555
Kyoto University Hospital
Kyoto, 606-8507
Ogaki Municipal Hospital
Ōgaki
Saga University Hospital
Saga
Kitasato University Hospital
Sagamihara
Kyorin University Hospital
Tama
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
China2 sites
Sir Run Run Shaw Hospital
Hangzhou
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an
South Korea2 sites
Korea University Anam Hospital
Seoul
Severance Hospital
Seoul
Taiwan2 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Taipei Veterans General Hospital (VGH)
Taipei
About this study
Official title: HD Mapping Observational Study - Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
- Being tested
- 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.
Catheter ablationDevice
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
| Study group | Role | What they receive |
|---|---|---|
| Inquiry™ AFocusII™ Double Loop | The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart. Receives: Device: Catheter ablation | |
| Advisor™ HD Grid, Sensor Enabled™ | The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Receives: Device: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
The rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion * 100%) with acute success is also displayed as the result of an automatic calculation.
Measured: End of Procedure
Number of Participants With Clinical Long-Term Success
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.
Measured: 12 months post-procedure
Number of Participants With AAD-Free Long-Term Success
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.
Measured: 12-month post-procedure
Secondary outcomes (9)
Overall Procedure Time
Defined as time from initial catheter insertion to final catheter removal. This is one measure of the amount of time it took for the physician to use invasive tools (catheters) during the procedure to investigate, diagnose, and treat the participant's heart condition.
Measured: During Procedure
Radiofrequency (RF) Time
Defined as duration of time radiofrequency energy is delivered. This is a measure the amount of time the physician was actively applying treatment to the heart to treat the participant's heart condition.
Measured: During Procedure
Fluoroscopy Time
Defined as total time subject is exposed to fluoroscopy. Fluoroscopy is a type of medical imaging that uses x-rays. This imaging is used by the physician to facilitate a safe and effective procedure. Less fluoroscopy time may help reduce the risk of issues related to x-ray exposure, however other factors such as fluroscopy intensity (not measured in this study) may also be important.
Measured: During Procedure
Mapping Time Associated With Mapping Arrhythmia
Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping). As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time provides a measure of how much time the physician spent creating, updating, and analyzing maps during the procedure. A short mapping time is not necessarily better or worse than a long mapping time, as other factors such as the amount and type of information gathered may also affect how useful the map is to the physician.
Measured: During Procedure
Number of Mapping Points Collected
Defined as total number of mapping points collected for the creation of each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected. A small number of mapping points collected is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.
Measured: During Procedure
Number of Mapping Points Used
Defined as the total number of mapping points used in each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. A small number of mapping points used is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.
Measured: During Procedure
Number of Used Mapping Points Per Minute
Defined as the total number of mapping points used divided by the relative mapping time. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time is a measure of how much time the physician spent collecting, updating, and analyzing the information in the map. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. The number of used mapping points per minute is a measure of how efficient the mapping process is. A larger number of used mapping points per minute may be associated with a more efficient mapping process. Mapping efficiency may be of interest to a physician, however other factors such as the type of information gathered may also be of interest.
Measured: During Procedure
Substrate Characteristics Identified
For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity or use other tests to characterize the state, function, or health of certain areas of the heart tissue, and to localize certain areas that may be problematic (substrate). These localized characteristics may provide information to the physician that could be used to treat the participant's heart condition. This outcome measure lists common substrate characteristics and the number of subjects for which the characteristic was found or otherwise used as part of the treatment plan.
Measured: During Procedure
Ablation Strategy(s) Used
Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians. A physician may use one or more strategies to treat the participant's heart condition, including selectively burning (ablating) certain areas of the heart. This outcome measure lists common ablation strategies and the number of participants that received treatment based on each strategy.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start11 Sep 2019
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD, Study director, EP Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022954
- Sponsor's protocol ID
- CRD975
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2019
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD Mapping Observational Study - Asia Pacific
- ClinicalTrials.gov ID
- NCT04022954
- Acronym / sponsor ID
- CRD975
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 29 Mar 2024
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 quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inquiry™ AFocusII™ Double Loop | – | Device: Catheter ablationThe Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart. |
| Advisor™ HD Grid, Sensor Enabled™ | – | Device: Catheter ablationThe Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations
Key inclusion criteria (7 listed)
- Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
- Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
- Subject is diagnosed with AF as defined by:
- Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
- Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation
Key exclusion criteria (8 listed)
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
- Participation in another clinical investigation that may confound the results of this study
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 |
|---|---|---|
| Catheter ablationInquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled | Device | Advisor™ HD Grid, Sensor Enabled™, Inquiry™ AFocusII™ Double Loop |
Primary outcome
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
Time frame: End of Procedure
The rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion * 100%) with acute success is also displayed as the result of an automatic calculation.
Number of Participants With Clinical Long-Term Success
Time frame: 12 months post-procedure
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.
Number of Participants With AAD-Free Long-Term Success
Time frame: 12-month post-procedure
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.
9 secondary outcomes
Overall Procedure Time
Time frame: During Procedure
Radiofrequency (RF) Time
Time frame: During Procedure
Fluoroscopy Time
Time frame: During Procedure
Mapping Time Associated With Mapping Arrhythmia
Time frame: During Procedure
Number of Mapping Points Collected
Time frame: During Procedure
Number of Mapping Points Used
Time frame: During Procedure
Number of Used Mapping Points Per Minute
Time frame: During Procedure
Substrate Characteristics Identified
Time frame: During Procedure
Ablation Strategy(s) Used
Time frame: During Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Paroxysmal Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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.
Kristin Ruffner, PhD study director
EP Program Director
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Abbott Medical Devices at 15 sites in 5 countries.
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 7 inclusion and 8 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 29 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 15 sites in Japan, China, South Korea, Taiwan, Hong Kong. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters. (time frame: End of Procedure). The study lists 3 primary outcomes in all. 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 29 Mar 2024.