- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03737929
Hybrid Therapy and Heart Team for Atrial Fibrillation (HT2AF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe Maury, MD
- Phone Number: +33 05-61-32-34-56
- Email: maury.p@chu-toulouse.fr
Study Contact Backup
- Name: Delphine Aravit
- Phone Number: +33 05 61 32 23 37
- Email: aravit.d@chu-toulouse.fr
Study Locations
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Paris, France
- Recruiting
- Cardiology-rytmology
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Contact:
- Estelle GANDJBAKHCH
- Email: estelle.gandjbakhch@aphp.fr
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Toulouse, France, 31059
- Recruiting
- CHU Toulouse, Hôpital Rangueil
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Contact:
- Philippe Maury, MD
- Phone Number: +33 05 61 32 34 56
- Email: maury.p@chu-toulouse.fr
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Contact:
- Anne Rollin, MD
- Email: rollin.a@chu-toulouse.fr
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Sub-Investigator:
- Bertrand Marcheix, MD
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Sub-Investigator:
- Etienne Grunenwald, MD
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Principal Investigator:
- Philippe Maury, MD
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Sub-Investigator:
- Anne Rollin, MD
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Toulouse, France
- Recruiting
- Cardiology-rytmology service
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Contact:
- Stephane COMBES
- Phone Number: +33 5 62 21 16 45
- Email: smbech@clinique-pasteur.com
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Contact:
- Issam ABOULIATIM
- Phone Number: +33 5 62 21 16 04
- Email: smccvt@clinique-pasteur.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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),
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hybrid ablation procedure
In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure.
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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
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Active Comparator: Percutaneous endocardial catheter ablation procedure
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
Time Frame: 12 months
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occurrence of at least one episode of AF/AT > 30 seconds in any ECG or Holter tracing (absence or presence)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AF/AT recurrence or major complication
Time Frame: 12 months
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Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)
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12 months
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Major complication related to the procedure
Time Frame: 12 months
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Percentage of patients developing a major complication related to the procedure
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12 months
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Major complication related to AF/AT
Time Frame: 12 months
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Percentage of patients developing a major complication related to AF/AT
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12 months
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Any complication (major or minor)
Time Frame: 12 months
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Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
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12 months
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Redo-procedure
Time Frame: 12 months
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Percentage of patients requiring a redo-procedure (new ablation in left atrium)
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12 months
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Cardioversion
Time Frame: 12 months
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Percentage of patients requiring a cardioversion
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12 months
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Number of hospitalizations
Time Frame: 12 months
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Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
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12 months
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Duration of the hospitalization
Time Frame: 1 month
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Mean duration of the hospitalization for AF ablation
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1 month
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Radiation exposure time
Time Frame: 12 months
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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.
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12 months
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Radiation exposure dosage
Time Frame: 12 months
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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.
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12 months
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Antiarrhythmic drugs
Time Frame: 12 months
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Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
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12 months
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Electrophysiological success
Time Frame: Day 0
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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.
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Day 0
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Evolution of quality of life
Time Frame: Between baseline to 12 months
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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.
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Between baseline to 12 months
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ICER
Time Frame: 12 months
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The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
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12 months
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ICUR
Time Frame: 12 months
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The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
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12 months
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Production costs
Time Frame: during the surgical procedure
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Production costs of the two strategies using the micro-costing approach
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during the surgical procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe Maury, MD, University Hospital of Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/17/0449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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