Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

NCT ID: NCT02630914

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

The AtriCure Synergy Ablation System

Intervention Type DEVICE

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

Interventions

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The AtriCure Synergy Ablation System

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand Marcheix, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, Midi Pyrenees, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 32241522 (View on PubMed)

Other Identifiers

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RC31/14/7424

Identifier Type: -

Identifier Source: org_study_id

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