Atrial FibrillationHISTORIC-AFNCT01622907
Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 10 sitesin 5 countries
- Study dates
- May 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 5 countries.
Antonio Curnis, MD. contact
10 sites in 5 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Heart Center Brandenburg- Immanuel
Bernau
JOHANNES ALBES, PROF.
JOHANNES ALBES, PROF.
- Not yet recruiting
Stadtische Kliniken
Dortmund
RALF KRAKOR, MD., ralf.krakor@debitel.de
RALF KRAKOR, MD.
- Not yet recruiting
Hamburg Uke
Hamburg
CHRISTIAN DETTER, MD, detter@uke.de
CHRISTIAN DETTER, Prof.
Italy3 sites, 3 recruiting
- Not yet recruiting
Ospedale Gavazzeni
Bergamo
GIAMPIERO ESPOSITO, MD, espositogp@hotmail.com
GIAMPIERO ESPOSITO, MD
- Recruiting
Univ. Hosp. Spedali Civili
Brescia, 25123
CLAUDIO - MUNERETTO, Prof., +39 030 3996401, munerett@med.unibs.it
Claudio - Muneretto, Professor
- Not yet recruiting
Univ.Hosp. Molinette
Torino
MAURO RINALDI, MD, mauro.rinaldi@unito.it
MAURO RINALDI, PROF.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Hammersmith Hospital
London
ROBERTO CASULA, rpcasula@yahoo.co.uk
ROBERTO CASULA
- Not yet recruiting
Royal Brompton
London
ANTHONY DE SOUZA, Mr., T.DeSouza@rbht.nhs.uk
ANTHONY DE SOUZA
France1 site, 1 recruiting
- Not yet recruiting
Louis Pradel Hospital
Lyon
FRANCOIS OBADIA, PROF., jean-francois.obadia@chu-lyon.fr
FRANCOIS OBADIA, PROF.
Poland1 site, 1 recruiting
- Not yet recruiting
University Hospital
Krakow
. JERZY SADOWSKI SADOWSKI, PROF., jsadowski@szpitaljp2.krakow.pl
JERZY SADOWSKI, PROF.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, radiofrequency, Epicardially applied radiofrequency ablation, Minimally invasive surgical approach
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pts Symptomatic Recurrent Persistent AF | Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for > 1-year < 5 years duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months following the end of the blanking period
Secondary outcomes (1)
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.
Measured: 9 months following the end of the blanking period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Meditrial SrL
- Responsible party
- Principal investigator, Claudio Muneretto, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- CLAUDIO MUNERETTO, PROF., Study chair, UNIV. HOSP. SPEDALI CIVILI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622907
- Sponsor's protocol ID
- HISTORIC AF 2011-10-11
- Acronym
- HISTORIC-AF
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16099734Muneretto 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.
PubMed 29156015
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF
- ClinicalTrials.gov ID
- NCT01622907
- Acronym / sponsor ID
- HISTORIC-AF / HISTORIC AF 2011-10-11
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, radiofrequency, Epicardially applied radiofrequency ablation, Minimally invasive surgical approach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Meditrial SrL
- Study start
- May 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts Symptomatic Recurrent Persistent AF | – | –Patients with Symptomatic Recurrent Persistent AF or Long standing AF,for > 1-year < 5 years duration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
SECONDARY EFFICACY ENDPOINTS: 24-hour Holter monitoring
Time frame: 9 months following the end of the blanking period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Background: PubMed 16099734Bisleri 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.
- Derived from this study: PubMed 29156015Muneretto 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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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Curnis, MD. contact
CLAUDIO MUNERETTO, PROF. study chair
UNIV. HOSP. SPEDALI CIVILI
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, United Kingdom, France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Muneretto, Prof. (+39 0303 995004, munerett@med.unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY EFFICACY ENDPOINT: 24-hour Holter monitoring (time frame: 9 months following the end of the blanking period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.