Atrial FibrillationPhase 3APPLENCT01932112
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
A Phase 3 study testing Adenosine arm in people with Atrial Fibrillation and Persistent Common Pulmonary Vein, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent Common Pulmonary Vein
- What is being tested?
- Adenosine arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to May 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed atrial fibrillation
- recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
- written informed consent
Who cannot join
- intracardiac thrombus
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation
Read the detailed description
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.
Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.
- Being tested
- Adenosine arm
- Keywords
- Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation 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.
Adenosine armDrug
Also called APPLE
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
| Study group | Role | What they receive |
|---|---|---|
| adenosine arm | Other | single arm study Receives: Drug: Adenosine arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Measured: 5 minutes after IV adenosine
Secondary outcomes (1)
Atrial Fibrillation Recurrence
At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)
Measured: between 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2015
- Study completionMay 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong seog Oh, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932112
- Sponsor's protocol ID
- APPLE
- Acronym
- APPLE
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2013
- Last updated
- 26 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim JY, Kim SH, Song IG, Kim YR, Kim TS, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Achievement of successful pulmonary vein isolation: methods of adenosine testing and incremental benefit of exit block. J Interv Card Electrophysiol. 2016 Sep;46(3):315-24. doi: 10.1007/s10840-016-0122-9. Epub 2016 Mar 9.
PubMed 26960977
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
- ClinicalTrials.gov ID
- NCT01932112
- Acronym / sponsor ID
- APPLE / APPLE
- Keywords
- Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 13 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation
Detailed description
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.
Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adenosine arm | Other | Drug: Adenosine armsingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed atrial fibrillation
- recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
- written informed consent
Key exclusion criteria (2 listed)
- intracardiac thrombus
- pregnancy
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 |
|---|---|---|
| Adenosine armAlso: APPLEAfter pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. | Drug | adenosine arm |
Primary outcome
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
Time frame: 5 minutes after IV adenosine
After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
1 secondary outcome
Atrial Fibrillation Recurrence
Time frame: between 0 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26960977Kim JY, Kim SH, Song IG, Kim YR, Kim TS, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Achievement of successful pulmonary vein isolation: methods of adenosine testing and incremental benefit of exit block. J Interv Card Electrophysiol. 2016 Sep;46(3):315-24. doi: 10.1007/s10840-016-0122-9. Epub 2016 Mar 9.
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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.
Yong seog Oh, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adenosine arm in people with Atrial Fibrillation and Persistent Common Pulmonary Vein, run by Yong Seog Oh at 1 site in South Korea.
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 2 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 26 Apr 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2016). 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?
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion (time frame: 5 minutes after IV adenosine). 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 NCT01932112, which also lists 1 linked publication.
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 26 Apr 2017.