Atrial FibrillationHT2AFNCT03737929
Hybrid Therapy and Heart Team for Atrial Fibrillation
A study testing Hybrid ablation and Percutaneous catheter ablation in people with Atrial Fibrillation, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold. 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 Percutaneous catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Jul 2019to 29 Jan 2024
- 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
- To have a history of symptomatic persistent atrial fibrillation (AF) (continuous AF lasting 7 days or more) or long-standing persistent AF (continuous AF lasting for more than 12 months)
- To be refractory to or intolerant to at least one class I (flecainide / propafenone) or III (sotalol / amiodarone) antiarrhythmic drug,
- To be at least 18 years of age,
- To agree to participate (signature of the informed consent)
Who cannot join
- A previous AF ablation procedure,
- A longstanding persistent AF > 3 years,
- A paroxysmal AF
- AF consecutive to electrolyte imbalance, thyroid disease, or other reversible non-cardiovascular cause,
- Presence of left atrial appendage (LAA) thrombus,
- Left atrial size ≥ 70ml/m² on transthoracic echocardiogram (TTE),
Show all 28Show fewer
- Left ventricular ejection fraction < 35%,
- Cardiac surgery (other than AF treatment) planned within 12 months,
- Contra-indication to heparin and/or oral anticoagulation
- Contra-indication to transoesophageal echocardiogram (TEE)
- Carotid stenosis > 80%,
- Active infection or sepsis
- Pleural adhesions,
- Elevated hemi diaphragm
- Proven and untreated sleep apnoea syndrome,
- Occurrence of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) during the past 6 months,
- History of blood clotting abnormalities
- Indication for a permanent dual antiplatelet therapy
- History of thoracic radiation,
- History of myocarditis or pericarditisHistory of cardiac tamponade,
- History of thoracotomy or cardiac surgery,
- Body-mass-index > 40 kg/m2,
- Significant lung dysfunction
- Contra-indication to anesthesia
- Patient with chronic obstructive pulmonary disease (COPD)
- Pregnancy,
- Life expectancy less than 12 months,
- Adults protected by the law
Trial locations and contacts
3 sites in 1 country.
France3 sites
Cardiology-rytmology
Paris
CHU Toulouse, Hôpital Rangueil
Toulouse, 31059
Cardiology-rytmology service
Toulouse
About this study
Official title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.
Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.
Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Hybrid ablation, Percutaneous catheter ablation
- Keywords
- Epicardial surgical ablation, Percutaneous endocardial catheter 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
In the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm
Percutaneous catheter ablationProcedure or surgery
In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid ablation procedure | Experimental | In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure. Receives: Procedure: Hybrid ablation |
| Percutaneous endocardial catheter ablation procedure | Active comparator | In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint). Receives: Procedure: Percutaneous catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
occurrence of at least one episode of AF/AT > 30 seconds in any ECG or Holter tracing (absence or presence)
Measured: 12 months
Secondary outcomes (16)
AF/AT recurrence or major complication
Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)
Measured: 12 months
Major complication related to the procedure
Percentage of patients developing a major complication related to the procedure
Measured: 12 months
Major complication related to AF/AT
Percentage of patients developing a major complication related to AF/AT
Measured: 12 months
Any complication (major or minor)
Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
Measured: 12 months
Redo-procedure
Percentage of patients requiring a redo-procedure (new ablation in left atrium)
Measured: 12 months
Cardioversion
Percentage of patients requiring a cardioversion
Measured: 12 months
Number of hospitalizations
Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
Measured: 12 months
Duration of the hospitalization
Mean duration of the hospitalization for AF ablation
Measured: 1 month
Radiation exposure time
Radiation exposure time (expressed in minutes) per patient. In case of redo-ablation during the follow-up, the total exposure time of the two first and the redo procedure will be totalized.
Measured: 12 months
Radiation exposure dosage
Radiation exposure dosage per patient. In case of redo-ablation during the follow-up, the total exposure dosage of the two first and the redo procedure will be totalized.
Measured: 12 months
Antiarrhythmic drugs
Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
Measured: 12 months
Electrophysiological success
Percentage of patients considered as reaching electrophysiological success, i.e. isolation of pulmonary veins and posterior box after epicardial surgical ablation. The validation will be performed during catheter ablation: isolation will be validated if there an entrance block in the posterior wall and in the pulmonary veins.
Measured: Day 0
Evolution of quality of life
Evolution of quality of life using the Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) scale. Symptom severity, physical and emotional components of quality of life, general well-being, and health care consumption related to AF are evaluated by this scale. The scale ranges from 0 to 4, corresponding to 0=no effect on functional quality of life to 4=a severe effect on life quality.
Measured: Between baseline to 12 months
ICER
The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Measured: 12 months
ICUR
The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Measured: 12 months
Production costs
Production costs of the two strategies using the micro-costing approach
Measured: during the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start8 Jul 2019
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Why it stopped: Difficulty finding patients
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Sponsor
- Investigators
- Philippe Maury, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737929
- Sponsor's protocol ID
- RC31/17/0449
- Acronym
- HT2AF
- Status last verified
- May 2026
- First submitted
- 31 Oct 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
- ClinicalTrials.gov ID
- NCT03737929
- Acronym / sponsor ID
- HT2AF / RC31/17/0449
- Conditions
- Atrial Fibrillation
- Keywords
- Epicardial surgical ablation, Percutaneous endocardial catheter ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty finding patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 13 Nov 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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.
Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.
Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid ablation procedure | Experimental | Procedure: Hybrid ablationIn the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure. |
| Percutaneous endocardial catheter ablation procedure | Active comparator | Procedure: Percutaneous catheter ablationIn the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To have a history of symptomatic persistent atrial fibrillation (AF) (continuous AF lasting 7 days or more) or long-standing persistent AF (continuous AF lasting for more than 12 months)
- To be refractory to or intolerant to at least one class I (flecainide / propafenone) or III (sotalol / amiodarone) antiarrhythmic drug,
- To be at least 18 years of age,
- To agree to participate (signature of the informed consent)
Key exclusion criteria (28 listed)
- A previous AF ablation procedure,
- A longstanding persistent AF > 3 years,
- A paroxysmal AF
- AF consecutive to electrolyte imbalance, thyroid disease, or other reversible non-cardiovascular cause,
- Presence of left atrial appendage (LAA) thrombus,
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 ablationIn the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm | Procedure or surgery | Hybrid ablation procedure |
| Percutaneous catheter ablationIn the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise). | Procedure or surgery | Percutaneous endocardial catheter ablation procedure |
Primary outcome
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
Time frame: 12 months
occurrence of at least one episode of AF/AT > 30 seconds in any ECG or Holter tracing (absence or presence)
16 secondary outcomes
AF/AT recurrence or major complication
Time frame: 12 months
Major complication related to the procedure
Time frame: 12 months
Major complication related to AF/AT
Time frame: 12 months
Any complication (major or minor)
Time frame: 12 months
Redo-procedure
Time frame: 12 months
Cardioversion
Time frame: 12 months
Number of hospitalizations
Time frame: 12 months
Duration of the hospitalization
Time frame: 1 month
Radiation exposure time
Time frame: 12 months
Radiation exposure dosage
Time frame: 12 months
Antiarrhythmic drugs
Time frame: 12 months
Electrophysiological success
Time frame: Day 0
Evolution of quality of life
Time frame: Between baseline to 12 months
ICER
Time frame: 12 months
ICUR
Time frame: 12 months
Production costs
Time frame: during the surgical procedure
Results and safety
The study was stopped early (reason given: Difficulty finding patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Philippe Maury, MD principal investigator
University Hospital of Toulouse
3 sites 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 Percutaneous catheter ablation in people with Atrial Fibrillation, run by University Hospital, Toulouse at 3 sites 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 28 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: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Difficulty finding patients). Results are not available in the source record.
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?
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence (time frame: 12 months). 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 1 Jun 2026.