Paroxysmal Atrial FibrillationNCT02438176
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
A study testing single trans-septal puncture and conventional bilateral groin puncture in people with Paroxysmal Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- single trans-septal puncture and conventional bilateral groin puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2015to 9 Mar 2018
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agreement of consent
- Patients who age more than 19
- patients who undergoing catheter ablation of atrial fibrillation
- Patients who are not vascular disease
Who cannot join
- patients who do not agree with study inclusion
- persistent AF
- Patients with vascular disease or venous anomaly
- Patients with structural abnormality of the heart
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
About this study
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- single trans-septal puncture, conventional bilateral groin puncture
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single trans-septal punctureProcedure or surgery
The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.
conventional bilateral groin punctureProcedure or surgery
Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.
| Study group | Role | What they receive |
|---|---|---|
| single puncture group | Experimental | single trans-septal puncture Receives: Procedure: single trans-septal puncture |
| conventional group | Active comparator | conventional bilateral groin puncture Receives: Procedure: conventional bilateral groin puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's subjective discomfort
Measured: 6month after procedure
Secondary outcomes (3)
Procedure time
Measured: 1day
Procedure related complication rate
Measured: 1 month after procedure
Long-term AF recurrence rate
Measured: 12 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start2 Jun 2015
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438176
- Sponsor's protocol ID
- 4-2015-0170
- Status last verified
- Feb 2019
- First submitted
- 3 May 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02438176
- Acronym / sponsor ID
- 4-2015-0170
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jun 2015
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 8 May 2015 (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.
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single puncture group | Experimental | Procedure: single trans-septal puncturesingle trans-septal puncture |
| conventional group | Active comparator | Procedure: conventional bilateral groin punctureconventional bilateral groin puncture |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients agreement of consent
- Patients who age more than 19
- patients who undergoing catheter ablation of atrial fibrillation
- Patients who are not vascular disease
Key exclusion criteria (4 listed)
- patients who do not agree with study inclusion
- persistent AF
- Patients with vascular disease or venous anomaly
- Patients with structural abnormality of the heart
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 |
|---|---|---|
| single trans-septal punctureThe investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization. | Procedure or surgery | single puncture group |
| conventional bilateral groin punctureBilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture. | Procedure or surgery | conventional group |
Primary outcome
Patient's subjective discomfort
Time frame: 6month after procedure
3 secondary outcomes
Procedure time
Time frame: 1day
Procedure related complication rate
Time frame: 1 month after procedure
Long-term AF recurrence rate
Time frame: 12 month after procedure
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 26 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single trans-septal puncture and conventional bilateral groin puncture in people with Paroxysmal Atrial Fibrillation, run by Yonsei University 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 4 inclusion and 4 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 Feb 2019. 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.
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?
Patient's subjective discomfort (time frame: 6month after procedure). 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 26 Feb 2019.