Atrial FibrillationPhase 4KPAFNCT01477983
Kansai Plus Atrial Fibrillation Trial
A Phase 4 study testing ATP guide additional ablation. and Antiarrhythmic drug (AAD) in people with Atrial Fibrillation, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ATP guide additional ablation. and Antiarrhythmic drug (AAD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,113 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Jul 2017
- Phase
- Phase 4
- 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing first catheter ablation including PV isolation for paroxysmal or persistent atrial fibrillation
- Patients who are 21-79 years old
- Able to be followed for one year in an out-patient clinic
- Willing to sign the consent form for participation
Who cannot join
- Contraindication or intolerance to adenosine triphosphate or Vaughan Williams class I or III antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation
- Age =< 20 years or => 80 years
- Renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)
- NYHA class IV heart failure
- Left ventricular ejection fraction < 40%
- Left atrial diameter > 55mm
Show all 16Show fewer
- Very long-lasting (>=5years) persistent atrial fibrillation
- Ineligible for optimal anticoagulant therapy
- History of myocardial infarction within the past 6 months
- Prior or planned open heart surgery
- Severe valve heart disease
- Unable to be followed in an out-patient clinic for one year
- Unwilling to sign the consent form for participation
- When the attending physician are unwilling to enroll the patient in the study
- When the attending physician consider inappropriate to enroll the patient in the study
- Those with severe procedural complications (EAST-AF trial only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kansai Plus Atrial Fibrillation Trial; UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate Trial; Efficacy of Antiarrhythmic Drugs Short-Term Use After Catheter Ablation for Atrial Fibrillation Trial
This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure (EAST-AF Trial).
Read the detailed description
Atrial fibrillation (AF) is a common tachyarrhythmia causing disabling symptoms and stroke. Although catheter ablation has been developed as curative therapy for AF, it is still associated with considerably high rate of AF recurrence, approximately 30-40% in patients with paroxysmal AF and 50-80% among those with persistent AF.
Because most ectopic beats triggering AF originate from myocardial sleeves in pulmonary veins (PVs), the mainstay of catheter ablation for AF is PV isolation. The major cause of early and late AF recurrence following successful PV isolation is considered to be electrical reconnection between left atrium (LA) and PVs. Therefore, it is important to establish permanent LA-PV disconnection, although high energy application is associated with increased risk of procedural complications, including cardiac tamponade, PV stenosis/occlusion and LA-esophageal fistula.
Adenosine or adenosine triphosphate (ATP) has been reported to unmask dormant electrical conduction between LA and PVs after successful PV isolation. Thus, adenosine or ATP guide additional ablation until disappearance of dormant electrical conduction has been proposed as adjunctive approach to establish permanent LA-PV disconnection and thereby decrease AF recurrence post ablation. However, only several small observational studies showed the efficacy of adenosine or ATP guide ablation, and this approach is not recognized as standard therapy.
On the other hand, sizable portion of AF recurrence early after ablation is considered to be due to irritability in LA from the ablation. Thus, short term use of antiarrhythmic drugs (AADs) after ablation has been proposed as adjunctive approach not only to prevent early AF recurrence, but also to improve long-term outcome by promoting reverse remodeling of LA through maintenance of sinus rhythm during the first 2-3 months period after ablation.
The 5A study, a recently reported single-center study, randomized 110 patients with paroxysmal AF to AAD or control group. In the AAD group, AAD was used for 6 weeks after ablation. Although AAD significantly reduced early AF recurrence during the first 6 weeks, discontinuation of the drug resulted in similar AF-free rates at 6 months. Considering the small number of patients enrolled in the 5A study, the results were not conclusive, lacking statistical power to determine the effect of short-tem use of AAD following successful ablation for AF on long-term clinical outcome. Also, this approach is expected to be more effective in patients with persistent AF rather than those with 'self-terminating' paroxysmal AF. In addition, 6 weeks may have been too short to promote reverse remodeling of LA.
Accordingly, we planned a 2x2 factorial randomized controlled trial (KPAF trial), evaluating the efficacy of ATP guide additional ablation and 90 days use of AADs post ablation. Approximately 2,000 patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP trial). Excluding those with severe procedural complications or those with substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to AAD or control group after the procedure (EAST-AF trial). Approximately 5% of the patients are expected to be excluded from the EAST-AF trial after ablation, but those patients will not be excluded from the UNDER-ATP trial, whose data will be analyzed by intention-to-treat manner. The follow-up duration is one year.
- Conditions
- Atrial Fibrillation
- Being tested
- ATP guide additional ablation., Antiarrhythmic drug (AAD), Control
- Keywords
- atrial fibrillation, catheter ablation, adenosine triphosphate, antiarrhythmic drugs
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATP guide additional ablation.Procedure or surgery
Also called The brand names of ATP; Adetphos-L, Trinosin-S
Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.
Antiarrhythmic drug (AAD)Drug
Also called Brand names; Tambocor, Pronon, Sotacor, Ancaron
Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.
ATP guide additional ablation.Procedure or surgery
Also called The brand names of ATP; Adetphos-L, Trinosin-S
Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.
ControlDrug
Also called Brand names; Tambocor, Pronon, Sotacor, Ancaron
Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.
ControlProcedure or surgery
Also called The brand names of ATP; Adetphos-L, Trinosin-S
Following successful PV isolation, intravenous ATP is not administered.
Antiarrhythmic drug (AAD)Drug
Also called Brand names; Tambocor, Pronon, Sotacor, Ancaron
Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.
ControlProcedure or surgery
Also called The brand names of ATP; Adetphos-L, Trinosin-S
Following successful PV isolation, intravenous ATP is not administered.
ControlDrug
Also called Brand names; Tambocor, Pronon, Sotacor, Ancaron
Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.
| Study group | Role | What they receive |
|---|---|---|
| ATP guide additional ablation - AAD | Active comparator | UNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: AAD for 90 days Receives: Procedure: ATP guide additional ablation.; Drug: Antiarrhythmic drug (AAD) |
| Control - AAD | Active comparator | UNDER-ATP trial: Control, EAST-AF trial: AAD for 90 days Receives: Procedure: Control; Drug: Antiarrhythmic drug (AAD) |
| ATP guide additinal ablation - Control | Active comparator | UNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: Control Receives: Procedure: ATP guide additional ablation.; Drug: Control |
| Control - Control | Active comparator | UNDER-ATP trial: Control, EAST-AF trial: Control Receives: Procedure: Control; Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy between 91 and 365 days after ablation. (Both trials)
Atrial tachyarrhythmias include atrial fibrillation, atrial tachycardia, and common or uncommon atrial flutter.
Antiarrhythmic drug (AAD) indicates Vaughan Williams class I or III drug.
Measured: 91 - 365 days
Secondary outcomes (12)
Repeat Ablation for atrial tachyarrhythmias. (Both trials)
Measured: 0 - 365 days
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* between 0 and 90 days after ablation. (Both trials)
- In patients assigned to AAD group, AAD therapy between 0 and 90 days post ablation is not regarded as this secondary outcome.
Measured: 0 - 90 days
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* after ablation. (Both trials)
- In patients assigned to AAD group, AAD therapy between 0 and 90 days post ablation is not regarded as this secondary outcome.
Measured: 0 - 365 days
Quality of Life (QOL) score. (Both trials)
Atrial Fibrillation Quality of Life Questionnaire（AFQLQ) is used in this study.
Measured: 0 - 365 days
Procedural complications including cardiac tamponade, thromboembolism, PV stenosis/occlusion, left atrium-esophageal fistula, and peri-esophageal injury. (UNDER-ATP trial)
Measured: 0 - 365 days
Total procedure time. (UNDER-ATP trial)
Measured: Day-0
Total fluoroscopy time. (UNDER-ATP trial)
Measured: Day-0
Total radiation dose. (UNDER-ATP trial)
Measured: Day-0
Total number and duration of radiofrequency energy applications. (UNDER-ATP trial)
Measured: Day-0
Total number and duration of radiofrequency energy applications for pulmonary vein isolation. (UNDER-ATP trial)
Measured: Day-0
Side effects of ATP including bronchial asthma, angina and sustained hypotension (<90mmHg or requiring vasopressor) during and after the procedure. (UNDER-ATP trial)
Measured: 0 - 365 days
Side effects of antiarrhythmic drugs (EAST-AF trial)
Measured: 0 - 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoshi Shizuta, Kyoto University, Graduate School of Medicine
- Investigators
- Satoshi Shizuta, MD, Principal investigator, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477983
- Sponsor's protocol ID
- KPAFKUHP
- Acronym
- KPAF
- Status last verified
- Aug 2017
- First submitted
- 12 Nov 2011
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kansai Plus Atrial Fibrillation Trial; UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate Trial; Efficacy of Antiarrhythmic Drugs Short-Term Use After Catheter Ablation for Atrial Fibrillation Trial
- ClinicalTrials.gov ID
- NCT01477983
- Acronym / sponsor ID
- KPAF / KPAFKUHP
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, adenosine triphosphate, antiarrhythmic drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,113 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Nov 2011 (estimated)
- 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.
This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure (EAST-AF Trial).
Detailed description
Atrial fibrillation (AF) is a common tachyarrhythmia causing disabling symptoms and stroke. Although catheter ablation has been developed as curative therapy for AF, it is still associated with considerably high rate of AF recurrence, approximately 30-40% in patients with paroxysmal AF and 50-80% among those with persistent AF.
Because most ectopic beats triggering AF originate from myocardial sleeves in pulmonary veins (PVs), the mainstay of catheter ablation for AF is PV isolation. The major cause of early and late AF recurrence following successful PV isolation is considered to be electrical reconnection between left atrium (LA) and PVs. Therefore, it is important to establish permanent LA-PV disconnection, although high energy application is associated with increased risk of procedural complications, including cardiac tamponade, PV stenosis/occlusion and LA-esophageal fistula.
Adenosine or adenosine triphosphate (ATP) has been reported to unmask dormant electrical conduction between LA and PVs after successful PV isolation. Thus, adenosine or ATP guide additional ablation until disappearance of dormant electrical conduction has been proposed as adjunctive approach to establish permanent LA-PV disconnection and thereby decrease AF recurrence post ablation. However, only several small observational studies showed the efficacy of adenosine or ATP guide ablation, and this approach is not recognized as standard therapy.
On the other hand, sizable portion of AF recurrence early after ablation is considered to be due to irritability in LA from the ablation. Thus, short term use of antiarrhythmic drugs (AADs) after ablation has been proposed as adjunctive approach not only to prevent early AF recurrence, but also to improve long-term outcome by promoting reverse remodeling of LA through maintenance of sinus rhythm during the first 2-3 months period after ablation.
The 5A study, a recently reported single-center study, randomized 110 patients with paroxysmal AF to AAD or control group. In the AAD group, AAD was used for 6 weeks after ablation. Although AAD significantly reduced early AF recurrence during the first 6 weeks, discontinuation of the drug resulted in similar AF-free rates at 6 months. Considering the small number of patients enrolled in the 5A study, the results were not conclusive, lacking statistical power to determine the effect of short-tem use of AAD following successful ablation for AF on long-term clinical outcome. Also, this approach is expected to be more effective in patients with persistent AF rather than those with 'self-terminating' paroxysmal AF. In addition, 6 weeks may have been too short to promote reverse remodeling of LA.
Accordingly, we planned a 2x2 factorial randomized controlled trial (KPAF trial), evaluating the efficacy of ATP guide additional ablation and 90 days use of AADs post ablation. Approximately 2,000 patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP trial). Excluding those with severe procedural complications or those with substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to AAD or control group after the procedure (EAST-AF trial). Approximately 5% of the patients are expected to be excluded from the EAST-AF trial after ablation, but those patients will not be excluded from the UNDER-ATP trial, whose data will be analyzed by intention-to-treat manner. The follow-up duration is one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ATP guide additional ablation - AAD | Active comparator | Procedure: ATP guide additional ablation., Drug: Antiarrhythmic drug (AAD)UNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: AAD for 90 days |
| Control - AAD | Active comparator | Procedure: Control, Drug: Antiarrhythmic drug (AAD)UNDER-ATP trial: Control, EAST-AF trial: AAD for 90 days |
| ATP guide additinal ablation - Control | Active comparator | Procedure: ATP guide additional ablation., Drug: ControlUNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: Control |
| Control - Control | Active comparator | Procedure: Control, Drug: ControlUNDER-ATP trial: Control, EAST-AF trial: Control |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing first catheter ablation including PV isolation for paroxysmal or persistent atrial fibrillation
- Patients who are 21-79 years old
- Able to be followed for one year in an out-patient clinic
- Willing to sign the consent form for participation
Key exclusion criteria (16 listed)
- Contraindication or intolerance to adenosine triphosphate or Vaughan Williams class I or III antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation
- Age =< 20 years or => 80 years
- Renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)
- NYHA class IV heart failure
- Left ventricular ejection fraction < 40%
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 |
|---|---|---|
| ATP guide additional ablation.Also: The brand names of ATP; Adetphos-L, Trinosin-SFollowing successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction. | Procedure or surgery | ATP guide additional ablation - AAD |
| Antiarrhythmic drug (AAD)Also: Brand names; Tambocor, Pronon, Sotacor, AncaronFollowing successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician. | Drug | ATP guide additional ablation - AAD |
| ATP guide additional ablation.Also: The brand names of ATP; Adetphos-L, Trinosin-SFollowing successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction. | Procedure or surgery | ATP guide additinal ablation - Control |
| ControlAlso: Brand names; Tambocor, Pronon, Sotacor, AncaronFollowing successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days. | Drug | ATP guide additinal ablation - Control |
| ControlAlso: The brand names of ATP; Adetphos-L, Trinosin-SFollowing successful PV isolation, intravenous ATP is not administered. | Procedure or surgery | Control - AAD |
| Antiarrhythmic drug (AAD)Also: Brand names; Tambocor, Pronon, Sotacor, AncaronFollowing successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician. | Drug | Control - AAD |
| ControlAlso: The brand names of ATP; Adetphos-L, Trinosin-SFollowing successful PV isolation, intravenous ATP is not administered. | Procedure or surgery | Control - Control |
| ControlAlso: Brand names; Tambocor, Pronon, Sotacor, AncaronFollowing successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days. | Drug | Control - Control |
Primary outcome
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy between 91 and 365 days after ablation. (Both trials)
Time frame: 91 - 365 days
Atrial tachyarrhythmias include atrial fibrillation, atrial tachycardia, and common or uncommon atrial flutter. Antiarrhythmic drug (AAD) indicates Vaughan Williams class I or III drug.
12 secondary outcomes
Repeat Ablation for atrial tachyarrhythmias. (Both trials)
Time frame: 0 - 365 days
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* between 0 and 90 days after ablation. (Both trials)
Time frame: 0 - 90 days
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* after ablation. (Both trials)
Time frame: 0 - 365 days
Quality of Life (QOL) score. (Both trials)
Time frame: 0 - 365 days
Procedural complications including cardiac tamponade, thromboembolism, PV stenosis/occlusion, left atrium-esophageal fistula, and peri-esophageal injury. (UNDER-ATP trial)
Time frame: 0 - 365 days
Total procedure time. (UNDER-ATP trial)
Time frame: Day-0
Total fluoroscopy time. (UNDER-ATP trial)
Time frame: Day-0
Total radiation dose. (UNDER-ATP trial)
Time frame: Day-0
Total number and duration of radiofrequency energy applications. (UNDER-ATP trial)
Time frame: Day-0
Total number and duration of radiofrequency energy applications for pulmonary vein isolation. (UNDER-ATP trial)
Time frame: Day-0
Side effects of ATP including bronchial asthma, angina and sustained hypotension (<90mmHg or requiring vasopressor) during and after the procedure. (UNDER-ATP trial)
Time frame: 0 - 365 days
Side effects of antiarrhythmic drugs (EAST-AF trial)
Time frame: 0 - 365 days
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 18 Aug 2017.
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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.
Satoshi Shizuta, MD principal investigator
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ATP guide additional ablation. and Antiarrhythmic drug (AAD) in people with Atrial Fibrillation, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
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 16 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 18 Aug 2017. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy between 91 and 365 days after ablation. (Both trials) (time frame: 91 - 365 days). 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 18 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.