Persistent Atrial FibrillationNCT03127423
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
A study testing Hybrid ablation and Thoracoscopic surgical ablation in people with Persistent Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Hybrid ablation and Thoracoscopic surgical ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least one anti-arrhythmic drugs
- Persistent AF lasting more than 1 year or with a left atrial diameter>50mm
Who cannot join
- Previous percutaneous catheter ablation or surgical ablation
- Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
- Left atrial diameter>60mm
- Previous thoracic or lung operation
- Left atrial thrombosis or left atrial appendage thrombosis
- Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)<70%、FEV1<50% anticipated value)
- Bilateral carotid artery stenosis>80%
- Refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
Read the detailed description
This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Hybrid ablation, Thoracoscopic surgical ablation
- Keywords
- Hybrid ablation, Thoracoscope
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid ablationProcedure or surgery
This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
Thoracoscopic surgical ablationProcedure or surgery
This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid ablation group | Experimental | Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation. Receives: Procedure: Hybrid ablation |
| Thoracoscopic surgical ablation group | Active comparator | Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set. Receives: Procedure: Thoracoscopic surgical ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate without any recurrence of AF
Without detections of AF (episodes longer than 30 seconds)
Measured: At 12-month after intervention
Secondary outcomes (6)
Burden of AF
Burden of AF according to Tele-ECG-Card lasting for one week
Measured: At 12-month after intervention
Quality of life score
Measured with questionnaire of AF effect on Quality of Life
Measured: preoperative and 12-month after intervention
Adverse events
Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.
Measured: 12 months follow up
Left atrial function
left atrial ejection fraction and left atrial expansion index
Measured: preoperative and postoperative
postoperative complications
perioperative complication of catheter ablation and thoracoscopic surgical abaltion
Measured: 30 days after operation
Survival rate without any recurrence of atrial tachyarrhythmia
Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting > 30 seconds.
Measured: At 12-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startDec 2016
- Primary completionDec 2022
- Study completionDec 2022
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.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhe Zheng, MD,PhD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127423
- Sponsor's protocol ID
- 2016-828
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03127423
- Acronym / sponsor ID
- 2016-828
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Hybrid ablation, Thoracoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Dec 2016
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 25 Apr 2017 (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.
Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
Detailed description
This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid ablation group | Experimental | Procedure: Hybrid ablationPatients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation. |
| Thoracoscopic surgical ablation group | Active comparator | Procedure: Thoracoscopic surgical ablationPatients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with at least one anti-arrhythmic drugs
- Persistent AF lasting more than 1 year or with a left atrial diameter>50mm
Key exclusion criteria (8 listed)
- Previous percutaneous catheter ablation or surgical ablation
- Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
- Left atrial diameter>60mm
- Previous thoracic or lung operation
- Left atrial thrombosis or left atrial appendage thrombosis
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 |
|---|---|---|
| Hybrid ablationThis intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously. | Procedure or surgery | Hybrid ablation group |
| Thoracoscopic surgical ablationThis intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation. | Procedure or surgery | Thoracoscopic surgical ablation group |
Primary outcome
Survival rate without any recurrence of AF
Time frame: At 12-month after intervention
Without detections of AF (episodes longer than 30 seconds)
6 secondary outcomes
Burden of AF
Time frame: At 12-month after intervention
Quality of life score
Time frame: preoperative and 12-month after intervention
Adverse events
Time frame: 12 months follow up
Left atrial function
Time frame: preoperative and postoperative
postoperative complications
Time frame: 30 days after operation
Survival rate without any recurrence of atrial tachyarrhythmia
Time frame: At 12-month after intervention
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 27 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Zhe Zheng, MD,PhD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid ablation and Thoracoscopic surgical ablation in people with Persistent Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 2 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 27 Apr 2023. 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 China. 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?
Survival rate without any recurrence of AF (time frame: At 12-month after intervention). 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 27 Apr 2023.