Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation

NCT03708471

Atrial Fibrillation

UNKNOWN NA

Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery

NCT00157807

Atrial Fibrillation Coronary Artery Disease

TERMINATED NA

Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

NCT06200311

Fibrillation, Atrial Atrial Cardiomyopathy

RECRUITING NA

Ablation or Surgery for Atrial Fibrillation (AF) Treatment

NCT00662701

Atrial Fibrillation

COMPLETED NA

Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

NCT03127423

Persistent Atrial Fibrillation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pts Symptomatic Recurrent Persistent AF

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudio Muneretto

M.D., Professor. Director, Department of Cardiac Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

CLAUDIO MUNERETTO, PROF.

Role: STUDY_CHAIR

UNIV. HOSP. SPEDALI CIVILI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.