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Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation (HISTORIC-AF)

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ClinicalTrials.gov Identifier: NCT01622907
Recruitment Status : Unknown
Verified June 2012 by Claudio Muneretto, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Meditrial SrL
Information provided by (Responsible Party):
Claudio Muneretto, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:

Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining surgical endoscopic and transcatheter techniques in a staged fashion provides superior clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting > 1 year but > 5 years.

The proposed procedure involves the creation of cardiac lesions with epicardially applied radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.


Condition or disease
Atrial Fibrillation

Detailed Description:

New ablative technologies have been developed to simplify the original "cut and sew" Cox Maze procedure so that it can now be used for routine treatment of AF in patients undergoing open-heart surgery, as well as in a stand-alone arrhythmia procedure. A minimally invasive, thoracoscopic surgical treatment of AF is able to address both the triggers for AF by pulmonary vein isolation and the left posterior atrial wall exclusion, which after the pulmonary veins is the next most important atrial substrate in the promotion of AF.

New hybrid procedures attempt to combine the success rate and the minimally invasive nature of thoracoscopic mini-Maze with the effectiveness and short recovery times associated with catheter ablation. The key is blocking signals that cause the arrhythmia from both outside (epicardial) and inside (endocardial) the heart.

Suboptimal results of both catheter ablation and surgery suggest that success in the treatment of long standing persistent AF and persistent lone AF will benefit from a close collaboration between the cardiothoracic surgeon and the electrophysiologist, to offer patients the best available combination of treatments for any given set of cardiovascular lesions.

Hybrid treatment for AF is being increasingly adopted in Europe and the United States and has been assessed for the treatment of AF at the Coordinating Center (Brescia, Italy) with promising results.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF
Study Start Date : May 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Pts Symptomatic Recurrent Persistent AF
Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for > 1-year < 5 years duration



Primary Outcome Measures :
  1. PRIMARY EFFICACY ENDPOINT: 24-hour Holter monitoring [ Time Frame: 9 months following the end of the blanking period ]
    The primary efficacy endpoint is the rate of therapeutic success, with a target rate of > 60%. Therapeutic success is defined as freedom from AF, during the 9 months following the end of the blanking period, based on 24-hour Holter monitor results, and freedom from AADs beginning at 6 months following surgery. The blanking period is 3 months following the surgical ablation procedure.


Secondary Outcome Measures :
  1. SECONDARY EFFICACY ENDPOINTS: 24-hour Holter monitoring [ Time Frame: 9 months following the end of the blanking period ]
    Rate of therapeutic success is defined as freedom from AF, 9 months following the end of the blanking period, based on 24-hour Holter monitoring. The target success rate is >60%. Rate of therapeutic success is defined as freedom from AF, during the 9 months following the end of the blanking period.The blanking period is 3 months following the surgical ablation procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Symptomatic Recurrent Persistent AF or Long Standing Persistent AF, defined as persistent AF for greater than 1-year but less than 5 years duration (according to the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation)
Criteria

Inclusion Criteria:

  • Subjects will be treated initially by thorocoscopic epicardial surgical RF ablation to create a box lesion around the pulmonary veins, ganglionated plexi, and superior vena cava-inferior vena cava (SVC-IVC) connecting lesions.

Four to maximum 8 weeks following the surgical ablation procedure, the patient is returning to the EP Laboratory to:

Assess integrity of the Box lesion Eliminate gaps in the surgical lesions when found Terminate fragmented potentials Perform a Caval-Tricuspid Isthmus (CTI) lesion line Upon completion of this procedure, integrity of the lesions is reassessed just prior to withdrawing the EP catheters from the LA.

Exclusion Criteria:

  • History of Recurrent Persistent or Long Standing Persistent AF for more than 5 years; Documented left atrial size (AP diameter) greater than 55 mm; Documented left ventricular ejection fraction (LVEF) of 40% or less; History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment; Significant underlying structural heart disease requiring surgical or procedural intervention; Previous heart surgery; Chronic obstructive pulmonary disease (< 70% predictive lung function); Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy; Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.); Pregnancy, planned pregnancy or breastfeeding; Concomitant cardiac surgery procedure planned.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622907


Contacts
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Contact: Claudio Muneretto, Prof. +39 0303 995004 munerett@med.unibs.it
Contact: Antonio Curnis, MD. antonio.curnis@libero.it

Locations
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France
Louis Pradel Hospital Not yet recruiting
Lyon, France
Contact: FRANCOIS OBADIA, PROF.       jean-francois.obadia@chu-lyon.fr   
Principal Investigator: FRANCOIS OBADIA, PROF.         
Germany
Heart Center Brandenburg- Immanuel Not yet recruiting
Bernau, Germany
Contact: JOHANNES ALBES, PROF.         
Principal Investigator: JOHANNES ALBES, PROF.         
Stadtische Kliniken Not yet recruiting
Dortmund, Germany
Contact: RALF KRAKOR, MD.       ralf.krakor@debitel.de   
Principal Investigator: RALF KRAKOR, MD.         
Hamburg Uke Not yet recruiting
Hamburg, Germany
Contact: CHRISTIAN DETTER, MD       detter@uke.de   
Principal Investigator: CHRISTIAN DETTER, Prof.         
Italy
Ospedale Gavazzeni Not yet recruiting
Bergamo, Italy
Contact: GIAMPIERO ESPOSITO, MD       espositogp@hotmail.com   
Principal Investigator: GIAMPIERO ESPOSITO, MD         
Univ. Hosp. Spedali Civili Recruiting
Brescia, Italy, 25123
Contact: CLAUDIO - MUNERETTO, Prof.    +39 030 3996401    munerett@med.unibs.it   
Principal Investigator: Claudio - Muneretto, Professor         
Principal Investigator: Antonio - Curnis, MD         
Univ.Hosp. Molinette Not yet recruiting
Torino, Italy
Contact: MAURO RINALDI, MD       mauro.rinaldi@unito.it   
Principal Investigator: MAURO RINALDI, PROF.         
Poland
University Hospital Not yet recruiting
Krakau, Poland
Contact: . JERZY SADOWSKI SADOWSKI, PROF.       jsadowski@szpitaljp2.krakow.pl   
Principal Investigator: JERZY SADOWSKI, PROF.         
United Kingdom
Hammersmith Hospital Not yet recruiting
London, United Kingdom
Contact: ROBERTO CASULA       rpcasula@yahoo.co.uk   
Principal Investigator: ROBERTO CASULA         
Royal Brompton Not yet recruiting
London, United Kingdom
Contact: ANTHONY DE SOUZA, Mr.       T.DeSouza@rbht.nhs.uk   
Principal Investigator: ANTHONY DE SOUZA         
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Meditrial SrL
Investigators
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Study Chair: CLAUDIO MUNERETTO, PROF. UNIV. HOSP. SPEDALI CIVILI

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claudio Muneretto, M.D., Professor. Director, Department of Cardiac Surgery, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT01622907     History of Changes
Other Study ID Numbers: HISTORIC AF 2011-10-11
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012
Keywords provided by Claudio Muneretto, Azienda Ospedaliera Spedali Civili di Brescia:
Catheter ablation, radiofrequency
Epicardially applied radiofrequency ablation
Minimally invasive surgical approach
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes