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Medical and Surgical Hybrid Treatment of Atrial Fibrillation. (HT2AF)

Primary Purpose

Atrial Fibrillation (AF)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The AtriCure Synergy Ablation System
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation (AF) focused on measuring Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
  • 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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

All patients will have the hybrid procedure of ablation of atrial fibrillation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of atrial fibrillation episode
Stroke Rate
Hospitalization for heart failure
The number of hospitalizations for heart failure after hybrid procedure
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)
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

Full Information

First Posted
December 11, 2015
Last Updated
December 18, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02630914
Brief Title
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
Acronym
HT2AF
Official Title
Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 the same time. This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (AF)
Keywords
Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All patients will have the hybrid procedure of ablation of atrial fibrillation.
Intervention Type
Device
Intervention Name(s)
The AtriCure Synergy Ablation System
Intervention Description
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
Primary Outcome Measure Information:
Title
Number of participants with complete procedure or not
Description
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.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Number of atrial fibrillation episode
Time Frame
12 months
Title
Stroke Rate
Time Frame
12 months
Title
Hospitalization for heart failure
Description
The number of hospitalizations for heart failure after hybrid procedure
Time Frame
12 months
Title
Evaluation of Quality of life (EQ-5D according to the survey-3L)
Description
The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L)
Time Frame
12 months
Title
The cost-effectiveness ration
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Marcheix, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Midi Pyrenees
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20802247
Citation
European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available. Erratum In: Eur Heart J. 2011 May;32(9):1172.
Results Reference
background
PubMed Identifier
19160031
Citation
Rich MW. Epidemiology of atrial fibrillation. J Interv Card Electrophysiol. 2009 Jun;25(1):3-8. doi: 10.1007/s10840-008-9337-8. Epub 2009 Jan 22.
Results Reference
background
PubMed Identifier
24516796
Citation
Pison L, Gelsomino S, Luca F, Parise O, Maessen JG, Crijns HJ, La Meir M. Effectiveness and safety of simultaneous hybrid thoracoscopic and endocardial catheter ablation of lone atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):38-44. doi: 10.3978/j.issn.2225-319X.2013.12.10.
Results Reference
background
PubMed Identifier
24516802
Citation
Pison L. Breakthroughs in hybrid management of stand-alone AF. Ann Cardiothorac Surg. 2014 Jan;3(1):78-9. doi: 10.3978/j.issn.2225-319X.2013.12.05. No abstract available.
Results Reference
background
PubMed Identifier
23904136
Citation
Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31.
Results Reference
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Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

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