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Hybrid Therapy and Heart Team for Atrial Fibrillation (HT2AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hybrid ablation
Percutaneous catheter ablation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Epicardial surgical ablation, Percutaneous endocardial catheter ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology-rytmologyRecruiting
  • CHU Toulouse, Hôpital RangueilRecruiting
  • Cardiology-rytmology serviceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid ablation procedure

Percutaneous endocardial catheter ablation procedure

Arm Description

In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step 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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Major complication related to the procedure
Percentage of patients developing a major complication related to the procedure
Major complication related to AF/AT
Percentage of patients developing a major complication related to AF/AT
Any complication (major or minor)
Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
Redo-procedure
Percentage of patients requiring a redo-procedure (new ablation in left atrium)
Cardioversion
Percentage of patients requiring a cardioversion
Number of hospitalizations
Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
Duration of the hospitalization
Mean duration of the hospitalization for AF ablation
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.
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.
Antiarrhythmic drugs
Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
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.
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.
ICER
The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
ICUR
The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Production costs
Production costs of the two strategies using the micro-costing approach

Full Information

First Posted
October 31, 2018
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
Collaborators
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03737929
Brief Title
Hybrid Therapy and Heart Team for Atrial Fibrillation
Acronym
HT2AF
Official Title
Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
AtriCure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Epicardial surgical ablation, Percutaneous endocardial catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid ablation procedure
Arm Type
Experimental
Arm Description
In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure.
Arm Title
Percutaneous endocardial catheter ablation procedure
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Hybrid ablation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous catheter ablation
Intervention Description
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 Measure Information:
Title
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
Description
occurrence of at least one episode of AF/AT > 30 seconds in any ECG or Holter tracing (absence or presence)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
AF/AT recurrence or major complication
Description
Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)
Time Frame
12 months
Title
Major complication related to the procedure
Description
Percentage of patients developing a major complication related to the procedure
Time Frame
12 months
Title
Major complication related to AF/AT
Description
Percentage of patients developing a major complication related to AF/AT
Time Frame
12 months
Title
Any complication (major or minor)
Description
Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
Time Frame
12 months
Title
Redo-procedure
Description
Percentage of patients requiring a redo-procedure (new ablation in left atrium)
Time Frame
12 months
Title
Cardioversion
Description
Percentage of patients requiring a cardioversion
Time Frame
12 months
Title
Number of hospitalizations
Description
Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
Time Frame
12 months
Title
Duration of the hospitalization
Description
Mean duration of the hospitalization for AF ablation
Time Frame
1 month
Title
Radiation exposure time
Description
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.
Time Frame
12 months
Title
Radiation exposure dosage
Description
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.
Time Frame
12 months
Title
Antiarrhythmic drugs
Description
Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
Time Frame
12 months
Title
Electrophysiological success
Description
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.
Time Frame
Day 0
Title
Evolution of quality of life
Description
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.
Time Frame
Between baseline to 12 months
Title
ICER
Description
The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Time Frame
12 months
Title
ICUR
Description
The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Time Frame
12 months
Title
Production costs
Description
Production costs of the two strategies using the micro-costing approach
Time Frame
during the surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Maury, MD
Phone
05-61-32-34-56
Ext
+33
Email
maury.p@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Aravit
Phone
05 61 32 23 37
Ext
+33
Email
aravit.d@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Maury, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology-rytmology
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle GANDJBAKHCH
Email
estelle.gandjbakhch@aphp.fr
Facility Name
CHU Toulouse, Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Maury, MD
Phone
05 61 32 34 56
Ext
+33
Email
maury.p@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Anne Rollin, MD
Email
rollin.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Philippe Maury, MD
First Name & Middle Initial & Last Name & Degree
Anne Rollin, MD
First Name & Middle Initial & Last Name & Degree
Bertrand Marcheix, MD
First Name & Middle Initial & Last Name & Degree
Etienne Grunenwald, MD
Facility Name
Cardiology-rytmology service
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane COMBES
Phone
5 62 21 16 45
Ext
+33
Email
smbech@clinique-pasteur.com
First Name & Middle Initial & Last Name & Degree
Issam ABOULIATIM
Phone
5 62 21 16 04
Ext
+33
Email
smccvt@clinique-pasteur.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Hybrid Therapy and Heart Team for Atrial Fibrillation

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