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

June 15, 2012 updated by: Claudio Muneretto, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Not yet recruiting
        • Louis Pradel Hospital
        • Contact:
        • Principal Investigator:
          • FRANCOIS OBADIA, PROF.
  • Germany
      • Bernau, Germany
        • Not yet recruiting
        • Heart Center Brandenburg- Immanuel
        • Contact:
          • JOHANNES ALBES, PROF.
        • Principal Investigator:
          • JOHANNES ALBES, PROF.
      • Dortmund, Germany
        • Not yet recruiting
        • Städtische Kliniken
        • Contact:
        • Principal Investigator:
          • RALF KRAKOR, MD.
      • Hamburg, Germany
        • Not yet recruiting
        • Hamburg Uke
        • Contact:
        • Principal Investigator:
          • CHRISTIAN DETTER, Prof.
  • Italy
      • Bergamo, Italy
        • Not yet recruiting
        • Ospedale Gavazzeni
        • Contact:
        • Principal Investigator:
          • GIAMPIERO ESPOSITO, MD
      • Brescia, Italy, 25123
        • Recruiting
        • Univ. Hosp. Spedali Civili
        • Contact:
        • Principal Investigator:
          • Claudio - Muneretto, Professor
        • Principal Investigator:
          • Antonio - Curnis, MD
      • Torino, Italy
        • Not yet recruiting
        • Univ.Hosp. Molinette
        • Principal Investigator:
          • MAURO RINALDI, PROF.
        • Contact:
  • Poland
      • Krakau, Poland
        • Not yet recruiting
        • University Hospital
        • Contact:
        • Principal Investigator:
          • JERZY SADOWSKI, PROF.
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Hammersmith Hospital
        • Contact:
        • Principal Investigator:
          • ROBERTO CASULA
      • London, United Kingdom
        • Not yet recruiting
        • Royal Brompton
        • Contact:
        • Principal Investigator:
          • ANTHONY DE SOUZA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months following the end of the blanking period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months following the end of the blanking period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

Meditrial SrL

Investigators

  • Study Chair: CLAUDIO MUNERETTO, PROF., Univ. Hosp. Spedali Civili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HISTORIC AF 2011-10-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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