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OpenTrials
Completed

NCT Number: NCT02630914

Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, Midi Pyrenees, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The AtriCure Synergy Ablation System

Device

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

Primary outcomes

  1. Number of participants with complete procedure or not

    Time frame: 3 hours

    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 outcomes

  1. Number of atrial fibrillation episode

    Time frame: 12 months

  2. Stroke Rate

    Time frame: 12 months

  3. Hospitalization for heart failure

    Time frame: 12 months

    The number of hospitalizations for heart failure after hybrid procedure

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

    Time frame: 12 months

    The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L)

  5. The cost-effectiveness ration

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.

Acronym: HT2AF

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2015
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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