Atrial FibrillationTHAT-LSPAFNCT03708471
Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation
A study testing Hybrid ablation and Thoracoscopic surgical ablation in people with Atrial Fibrillation, run by Guangdong Academy of Medical Sciences at 1 site in China.
Trial summary
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 150 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2018to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old.
- Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively.
- Written informed consent
Who cannot join
- Secondary atrial fibrillation caused by other reversible diseases.
- Left atrial diameter >55mm confrimed by Transthoracic echocardiography.
- Intracardial mass or thrombus.
- Previous cardiac surgery.
- Uncontrolled heart failure or LVEF less than 30%.
- Severe chest wall deformity.
Show all 10Show fewer
- Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis.
- Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure).
- Life expectancy less than 2 years (e.g. patients with MODS or cancer)
- Unsuitable for radiation exposure (e.g. pregnancy)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Huiming Guo, MD., PhD., +86 13609089789, guohuiming@163.net
Yuyuan Zhang, Jr.
About this study
Official title: Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it.
This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.
Read the detailed description
In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients.
During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.
- Conditions
- Atrial Fibrillation
- Being tested
- Hybrid ablation, Thoracoscopic surgical ablation
- Keywords
- Atrial fibrillation, Hybrid ablation, Surgical 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.
Hybrid ablationProcedure or surgery
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
Thoracoscopic surgical ablationProcedure or surgery
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
| Study group | Role | What they receive |
|---|---|---|
| Two-stage hybrid abltaion | Experimental | After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control. Receives: Procedure: Hybrid ablation |
| Thoracosopic surgical ablation | Active comparator | After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control. Receives: Procedure: Thoracoscopic surgical ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmia recurrence
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
Measured: 24 months after blanking-period.
Secondary outcomes (2)
Systemic atrial embolism
Including cerebral infarction and other peripheral atrial embolism
Measured: 24 months after blanking-period.
Left atrial thrombus
New-onset left atrial thrombus confirmed by TEE or TTE
Measured: At 3months, 6months, 12months, 18months, 24months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start4 Mar 2018
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiming Guo, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708471
- Sponsor's protocol ID
- THAT-LSPAF
- Acronym
- THAT-LSPAF
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03708471
- Acronym / sponsor ID
- THAT-LSPAF / THAT-LSPAF
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Hybrid ablation, Surgical ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangdong Academy of Medical SciencesUniversity, hospital or other
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Oct 2018 (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.
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it.
This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.
Detailed description
In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients.
During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-stage hybrid abltaion | Experimental | Procedure: Hybrid ablationAfter thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control. |
| Thoracosopic surgical ablation | Active comparator | Procedure: Thoracoscopic surgical ablationAfter thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years old.
- Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively.
- Written informed consent
Key exclusion criteria (10 listed)
- Secondary atrial fibrillation caused by other reversible diseases.
- Left atrial diameter >55mm confrimed by Transthoracic echocardiography.
- Intracardial mass or thrombus.
- Previous cardiac surgery.
- Uncontrolled heart failure or LVEF less than 30%.
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 including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control. | Procedure or surgery | Two-stage hybrid abltaion |
| Thoracoscopic surgical ablationThis intervention including thoracoscopic surgical ablation and cardiovascular risk control. | Procedure or surgery | Thoracosopic surgical ablation |
Primary outcome
Atrial tachyarrhythmia recurrence
Time frame: 24 months after blanking-period.
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
2 secondary outcomes
Systemic atrial embolism
Time frame: 24 months after blanking-period.
Left atrial thrombus
Time frame: At 3months, 6months, 12months, 18months, 24months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
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 Atrial Fibrillation, run by Guangdong Academy of Medical Sciences 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 3 inclusion and 10 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 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiming Guo, MD, PhD (+86 13609089789, guohuiming@163.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial tachyarrhythmia recurrence (time frame: 24 months after blanking-period.). 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 11 Feb 2020.