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Hybrid Therapy and Heart Team for Atrial Fibrillation (HT2AF)

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ClinicalTrials.gov Identifier: NCT03737929
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
AtriCure, Inc.
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Hybrid ablation Procedure: Percutaneous catheter ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.
Procedure: Hybrid ablation
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

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).
Procedure: Percutaneous catheter ablation
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).




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. AF/AT recurrence or major complication [ Time Frame: 12 months ]
    Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)

  2. Major complication related to the procedure [ Time Frame: 12 months ]
    Percentage of patients developing a major complication related to the procedure

  3. Major complication related to AF/AT [ Time Frame: 12 months ]
    Percentage of patients developing a major complication related to AF/AT

  4. Any complication (major or minor) [ Time Frame: 12 months ]
    Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT

  5. Redo-procedure [ Time Frame: 12 months ]
    Percentage of patients requiring a redo-procedure (new ablation in left atrium)

  6. Cardioversion [ Time Frame: 12 months ]
    Percentage of patients requiring a cardioversion

  7. Number of hospitalizations [ Time Frame: 12 months ]
    Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure

  8. Duration of the hospitalization [ Time Frame: 1 month ]
    Mean duration of the hospitalization for AF ablation

  9. Radiation exposure time [ Time Frame: 12 months ]
    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.

  10. Radiation exposure dosage [ Time Frame: 12 months ]
    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.

  11. Antiarrhythmic drugs [ Time Frame: 12 months ]
    Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs

  12. Electrophysiological success [ Time Frame: Day 0 ]
    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.

  13. Evolution of quality of life [ Time Frame: Between baseline to 12 months ]
    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.

  14. ICER [ Time Frame: 12 months ]
    The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling

  15. ICUR [ Time Frame: 12 months ]
    The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling

  16. Production costs [ Time Frame: during the surgical procedure ]
    Production costs of the two strategies using the micro-costing approach



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737929


Contacts
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Contact: Philippe Maury, MD 05-61-32-34-56 ext +33 maury.p@chu-toulouse.fr
Contact: Delphine Aravit 05 61 32 23 37 ext +33 aravit.d@chu-toulouse.fr

Locations
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France
CHU Toulouse, Hôpital Rangueil Recruiting
Toulouse, France, 31059
Contact: Philippe Maury, MD    05 61 32 34 56 ext +33    maury.p@chu-toulouse.fr   
Contact: Anne Rollin, MD       rollin.a@chu-toulouse.fr   
Principal Investigator: Philippe Maury, MD         
Sub-Investigator: Anne Rollin, MD         
Sub-Investigator: Bertrand Marcheix, MD         
Sub-Investigator: Etienne Grunenwald, MD         
Sponsors and Collaborators
University Hospital, Toulouse
AtriCure, Inc.
Investigators
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Principal Investigator: Philippe Maury, MD University Hospital of Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03737929     History of Changes
Other Study ID Numbers: RC31/17/0449
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Epicardial surgical ablation
Percutaneous endocardial catheter ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes