Atrial Fibrillation (AF)HT2AFNCT02630914
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
A study testing The AtriCure Synergy Ablation System in people with Atrial Fibrillation (AF), run by University Hospital, Toulouse at 1 site in France.
Trial summary
The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation. This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- The AtriCure Synergy Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with complex AF defined by the following criteria :
- AF> 1 week or long term persistent> 1 year
- AND Symptomatic
- AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic
Who cannot join
- The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF:
- Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
- Recent AF for which a simple gesture is intracavitary considered sufficient
- Permanent AF
- Asymptomatic AF
- Very old AF (> 5 years) or atrial major ectasia (> 60 mm)
Show all 16Show fewer
- Need another surgery (valve bypass coronary)
- Previous history of sternotomy or thoracotomy
- High-risk surgical or anesthetic Patient
- BMI> 35
- Sleep Apnea
- Ejection fraction <35%
- Thoracic trauma history
- Veins Pulmonary stenosis> 50%
- Hyperthyroidism
- Thrombus in LAA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.
The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.
This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.
This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- The AtriCure Synergy Ablation System
- Keywords
- Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AtriCure Synergy Ablation SystemDevice
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients will have the hybrid procedure of ablation of atrial fibrillation. Receives: Device: The AtriCure Synergy Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete procedure or not
At the end of the intervention, the doctor evaluates whether the procedure was complete with electric exclusion of the posterior wall of the left atrium and the 4 pulmonary veins.
Measured: 3 hours
Secondary outcomes (5)
Number of atrial fibrillation episode
Measured: 12 months
Stroke Rate
Measured: 12 months
Hospitalization for heart failure
The number of hospitalizations for heart failure after hybrid procedure
Measured: 12 months
Evaluation of Quality of life (EQ-5D according to the survey-3L)
The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L)
Measured: 12 months
The cost-effectiveness ration
Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients will be counted during the follow-up year.
The effectiveness will be assessed against the complications of strategy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Marcheix, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630914
- Sponsor's protocol ID
- RC31/14/7424
- Acronym
- HT2AF
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rollin A, Mandel F, Grunenwald E, Mondoly P, Monteil B, Marcheix B, Maury P. Hybrid surgical ablation for persistent or long standing persistent atrial fibrillation: A French single centre experience. Ann Cardiol Angeiol (Paris). 2020 Apr;69(2):86-92. doi: 10.1016/j.ancard.2020.03.008. Epub 2020 Mar 30.
PubMed 32241522
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.
- ClinicalTrials.gov ID
- NCT02630914
- Acronym / sponsor ID
- HT2AF / RC31/14/7424
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Dec 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 objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.
This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.
This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: The AtriCure Synergy Ablation SystemAll patients will have the hybrid procedure of ablation of atrial fibrillation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AF> 1 week or long term persistent> 1 year
- AND Symptomatic
- AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic
Key exclusion criteria (16 listed)
- The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF:
- Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
- Recent AF for which a simple gesture is intracavitary considered sufficient
- Permanent AF
- Asymptomatic AF
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 |
|---|---|---|
| The AtriCure Synergy Ablation SystemThe AtriCure Synergy Ablation System will be used on all patients for AF ablation. | Device | Intervention |
Primary outcome
Number of participants with complete procedure or not
Time frame: 3 hours
At the end of the intervention, the doctor evaluates whether the procedure was complete with electric exclusion of the posterior wall of the left atrium and the 4 pulmonary veins.
5 secondary outcomes
Number of atrial fibrillation episode
Time frame: 12 months
Stroke Rate
Time frame: 12 months
Hospitalization for heart failure
Time frame: 12 months
Evaluation of Quality of life (EQ-5D according to the survey-3L)
Time frame: 12 months
The cost-effectiveness ration
Time frame: 12 months
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 10 Dec 2025.
- Results publication: PubMed 32241522Rollin A, Mandel F, Grunenwald E, Mondoly P, Monteil B, Marcheix B, Maury P. Hybrid surgical ablation for persistent or long standing persistent atrial fibrillation: A French single centre experience. Ann Cardiol Angeiol (Paris). 2020 Apr;69(2):86-92. doi: 10.1016/j.ancard.2020.03.008. Epub 2020 Mar 30.
- 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.
Bertrand Marcheix, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The AtriCure Synergy Ablation System in people with Atrial Fibrillation (AF), run by University Hospital, Toulouse at 1 site in France.
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 16 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 10 Dec 2025. 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 France. 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?
Number of participants with complete procedure or not (time frame: 3 hours). 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 NCT02630914, 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 10 Dec 2025.