Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation (HISTORIC-AF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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|
|Estimated Enrollment :||100 participants|
|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|
Pts Symptomatic Recurrent Persistent AF
Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for > 1-year < 5 years duration
- 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 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.
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
|Contact: Claudio Muneretto, Prof.||+39 0303 firstname.lastname@example.org|
|Contact: Antonio Curnis, MD.||email@example.com|
|Louis Pradel Hospital||Not yet recruiting|
|Contact: FRANCOIS OBADIA, PROF. firstname.lastname@example.org|
|Principal Investigator: FRANCOIS OBADIA, PROF.|
|Heart Center Brandenburg- Immanuel||Not yet recruiting|
|Contact: JOHANNES ALBES, PROF.|
|Principal Investigator: JOHANNES ALBES, PROF.|
|Stadtische Kliniken||Not yet recruiting|
|Contact: RALF KRAKOR, MD. email@example.com|
|Principal Investigator: RALF KRAKOR, MD.|
|Hamburg Uke||Not yet recruiting|
|Contact: CHRISTIAN DETTER, MD firstname.lastname@example.org|
|Principal Investigator: CHRISTIAN DETTER, Prof.|
|Ospedale Gavazzeni||Not yet recruiting|
|Contact: GIAMPIERO ESPOSITO, MD email@example.com|
|Principal Investigator: GIAMPIERO ESPOSITO, MD|
|Univ. Hosp. Spedali Civili||Recruiting|
|Brescia, Italy, 25123|
|Contact: CLAUDIO - MUNERETTO, Prof. +39 030 3996401 firstname.lastname@example.org|
|Principal Investigator: Claudio - Muneretto, Professor|
|Principal Investigator: Antonio - Curnis, MD|
|Univ.Hosp. Molinette||Not yet recruiting|
|Contact: MAURO RINALDI, MD email@example.com|
|Principal Investigator: MAURO RINALDI, PROF.|
|University Hospital||Not yet recruiting|
|Contact: . JERZY SADOWSKI SADOWSKI, PROF. firstname.lastname@example.org|
|Principal Investigator: JERZY SADOWSKI, PROF.|
|Hammersmith Hospital||Not yet recruiting|
|London, United Kingdom|
|Contact: ROBERTO CASULA email@example.com|
|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|
|Study Chair:||CLAUDIO MUNERETTO, PROF.||UNIV. HOSP. SPEDALI CIVILI|