Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation

NCT01622907 | Unknown DMC

• 1 other identifier: HISTORIC AF 2011-10-11
• Study Type: observational
• Target: 100
• Locations: 5 countries
• Sites: 10

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.

Conditions

Atrial Fibrillation

Keywords

Catheter ablation, radiofrequency; Epicardially applied radiofrequency ablation; Minimally invasive surgical approach

Outcome Measures

Primary Outcomes (1)

• PRIMARY EFFICACY ENDPOINT: 24-hour Holter monitoring

  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 Outcomes (1)

• SECONDARY EFFICACY ENDPOINTS: 24-hour Holter monitoring

  9 months following the end of the blanking period

Study Arms (1)

Pts Symptomatic Recurrent Persistent AF

Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for \> 1-year \< 5 years duration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Meditrial SrL: collaborator

Study Sites (10)

Louis Pradel Hospital

Lyon, France

NOT YET RECRUITING

Heart Center Brandenburg- Immanuel

Bernau, Germany

NOT YET RECRUITING

Stadtische Kliniken

Dortmund, Germany

NOT YET RECRUITING

Hamburg Uke

Hamburg, Germany

NOT YET RECRUITING

Ospedale Gavazzeni

Bergamo, Italy

NOT YET RECRUITING

Univ. Hosp. Spedali Civili

Brescia, 25123, Italy

RECRUITING

Univ.Hosp. Molinette

Torino, Italy

NOT YET RECRUITING

University Hospital

Krakow, Poland

NOT YET RECRUITING

Hammersmith Hospital

London, United Kingdom

NOT YET RECRUITING

Royal Brompton

London, United Kingdom

NOT YET RECRUITING

Related Publications (2)

• Bisleri G, Curnis A, Bottio T, Mascioli G, Muneretto C. The need of a hybrid approach for the treatment of atrial fibrillation. Heart Surg Forum. 2005;8(5):E326-30. doi: 10.1532/HSF98.20051125.

  PMID: 16099734 BACKGROUND

• Muneretto C, Bisleri G, Rosati F, Krakor R, Giroletti L, Di Bacco L, Repossini A, Moltrasio M, Curnis A, Tondo C, Polvani G. European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):740-745. doi: 10.1093/ejcts/ezx162.

  PMID: 29156015 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CLAUDIO MUNERETTO, PROF.

  UNIV. HOSP. SPEDALI CIVILI

  STUDY CHAIR

Central Study Contacts

Claudio Muneretto, Prof.

CONTACT

+39 0303 995004; munerett@med.unibs.it

Antonio Curnis, MD.

CONTACT

antonio.curnis@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor. Director, Department of Cardiac Surgery

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2015
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

FR (1); PL (1); IT (3); GB (2); DE (3)