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| Name | Class |
|---|---|
| Meditrial SrL | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pts Symptomatic Recurrent Persistent AF | Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for > 1-year < 5 years duration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SECONDARY EFFICACY ENDPOINTS: 24-hour Holter monitoring | 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. |
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Inclusion Criteria:
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:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Muneretto, Prof. | Contact | +39 0303 995004 | munerett@med.unibs.it | |
| Antonio Curnis, MD. | Contact | antonio.curnis@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| CLAUDIO MUNERETTO, PROF. | UNIV. HOSP. SPEDALI CIVILI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Pradel Hospital | Not yet recruiting | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16099734 | Background | 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. | |
| 29156015 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 29, 2016 | |
| Reset | Nov 17, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 29, 2016 | Nov 17, 2016 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 9 months following the end of the blanking period |
| Heart Center Brandenburg- Immanuel | Not yet recruiting | Bernau | Germany |
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| Stadtische Kliniken | Not yet recruiting | Dortmund | Germany |
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| Hamburg Uke | Not yet recruiting | Hamburg | Germany |
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| Ospedale Gavazzeni | Not yet recruiting | Bergamo | Italy |
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| Univ. Hosp. Spedali Civili | Recruiting | Brescia | 25123 | Italy |
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| Univ.Hosp. Molinette | Not yet recruiting | Torino | Italy |
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| University Hospital | Not yet recruiting | Krakow | Poland |
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| Hammersmith Hospital | Not yet recruiting | London | United Kingdom |
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| Royal Brompton | Not yet recruiting | London | United Kingdom |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |