Medical and Surgical Hybrid Treatment of Atrial Fibrillat... | NCT02630914

Studies
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

NCT02630914

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Dec 10, 2025Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation (AF)

Interventions

The AtriCure Synergy Ablation System

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Dec 11, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2025

Last Update Posted Date

Dec 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	All patients will have the hybrid procedure of ablation of atrial fibrillation.	Device: The AtriCure Synergy Ablation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The AtriCure Synergy Ablation System	Device	The AtriCure Synergy Ablation System will be used on all patients for AF ablation.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of atrial fibrillation episode		12 months
Stroke Rate		12 months
Hospitalization for heart failure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bertrand Marcheix, MD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Toulouse		Toulouse	Midi Pyrenees	31059	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32241522	Result	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.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes