Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

NCT02630914 | Completed DMC

• 1 other identifier: RC31/14/7424
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Epicardial surgical removal; Closure of the left atrial; Left atrial appendage (LAA)

Outcome Measures

Primary Outcomes (1)

• 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.

  3 hours

Secondary Outcomes (5)

• Number of atrial fibrillation episode

  12 months

• Stroke Rate

  12 months

• Hospitalization for heart failure

  12 months

• Evaluation of Quality of life (EQ-5D according to the survey-3L)

  12 months

• The cost-effectiveness ration

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: The AtriCure Synergy Ablation System

Interventions

The AtriCure Synergy Ablation System DEVICE

The AtriCure Synergy Ablation System will be used on all patients for AF ablation.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi Pyrenees, 31059, France

Location

Related Publications (1)

• Rollin A, Mandel F, Grunenwald E, Mondoly P, Monteil B, Marcheix B, Maury P. Hybrid surgical ablation for persistent or long standing persistent atrial fibrillation: A French single centre experience. Ann Cardiol Angeiol (Paris). 2020 Apr;69(2):86-92. doi: 10.1016/j.ancard.2020.03.008. Epub 2020 Mar 30.

  PMID: 32241522 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand Marcheix, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 10, 2025

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)