Persistent Atrial FibrillationPhase 4LEAP-AFNCT04405258
Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial
A Phase 4 study testing Pulmonary vein isolation and Left posterior wall isolation in people with Persistent Atrial Fibrillation and Catheter Ablation, run by Institute for Clinical Effectiveness, Japan at 1 site in Japan.
Trial summary
The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation
- What is being tested?
- Pulmonary vein isolation and Left posterior wall isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteJapan
- Study dates
- 8 Jun 2020to 30 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for first catheter ablation of persistent atrial fibrillation
- Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
- Patients with persisting duration of atrial fibrillation less than 3 years
- Patients with left atrial diameter less than 50mm
- Patients who can be followed up for 18 months
- Patients with written informed consent
Who cannot join
- Patients who can not be received adequate anticoagulation therapy
- Patients with history of myocardial infarction within 6 months
- Patients with history of open heart surgery
- Patients scheduled for open heart surgery
- Patients with severe valvular heart disease
- Patients during pregnancy
- Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
- Patients considered unsuitable for study by the attending physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation
The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).
Read the detailed description
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Posterior Wall Isolation
- Being tested
- Pulmonary vein isolation, Left posterior wall isolation
- Keywords
- Persistent atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Posterior wall isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
Left posterior wall isolationProcedure or surgery
Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
| Study group | Role | What they receive |
|---|---|---|
| PVI alone | Active comparator | Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation Receives: Procedure: Pulmonary vein isolation |
| PVI and PWI | Active comparator | Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation Receives: Procedure: Left posterior wall isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
Measured: 18 months
Secondary outcomes (6)
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation
Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
Measured: 18 months
Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation
Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
Measured: 90 days
Repeated ablation of atrial tachyarrhythmia
Measured: 18 months
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation
Measured: 18 months
Atrial Fibrillation Quality of Life Questionnaire
Atrial Fibrillation Quality of Life Questionnaire
Measured: 18 months
Complications of ablation procedure
Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start8 Jun 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keisuke Okawa, MD, Principal investigator, Kagawa Prefectural Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405258
- Sponsor's protocol ID
- 947
- Acronym
- LEAP-AF
- Status last verified
- Jun 2024
- First submitted
- 22 May 2020
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available from the data center upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04405258
- Acronym / sponsor ID
- LEAP-AF / 947
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Posterior Wall Isolation
- Keywords
- Persistent atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Posterior wall isolation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness, JapanUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 May 2020 (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 purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).
Detailed description
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI alone | Active comparator | Procedure: Pulmonary vein isolationPulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation |
| PVI and PWI | Active comparator | Procedure: Left posterior wall isolationPulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for first catheter ablation of persistent atrial fibrillation
- Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
- Patients with persisting duration of atrial fibrillation less than 3 years
- Patients with left atrial diameter less than 50mm
- Patients who can be followed up for 18 months
Key exclusion criteria (8 listed)
- Patients who can not be received adequate anticoagulation therapy
- Patients with history of myocardial infarction within 6 months
- Patients with history of open heart surgery
- Patients scheduled for open heart surgery
- Patients with severe valvular heart disease
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 |
|---|---|---|
| Pulmonary vein isolationPulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation | Procedure or surgery | PVI alone |
| Left posterior wall isolationPulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation | Procedure or surgery | PVI and PWI |
Primary outcome
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
Time frame: 18 months
Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
6 secondary outcomes
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation
Time frame: 18 months
Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation
Time frame: 90 days
Repeated ablation of atrial tachyarrhythmia
Time frame: 18 months
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation
Time frame: 18 months
Atrial Fibrillation Quality of Life Questionnaire
Time frame: 18 months
Complications of ablation procedure
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available from the data center upon reasonable request.
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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.
Keisuke Okawa, MD principal investigator
Kagawa Prefectural Central Hospital
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 Pulmonary vein isolation and Left posterior wall isolation in people with Persistent Atrial Fibrillation and Catheter Ablation, run by Institute for Clinical Effectiveness, Japan 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 6 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
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?
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation (time frame: 18 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 14 Jun 2024.