The objective of the study is to demonstrate that the creation of cardiac lesions with epicardially applied RF ablation through a minimally invasive surgical (MIS) approach plus EP ablation performed when needed at least 3 months later enhances the…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the rate of therapeutic success of
thoracoscopic surgical ablation, with a target rate of > 60%. Surgical
ablation success is defined as freedom from AF without the need for EP
ablation, during 12 months after surgery, based on 24-hour Holter monitor
results, and freedom from AADs beginning at 6 months following surgery.
Arrhytmias during the blanking period (first 3 months after ablation) are
excluded from evaluation.
The primary safety endpoint is a composite safety endpoint consisting of the
incidence of the following early onset serious adverse events (SAEs) (i.e.,
within 30 days of the last RF ablation procedure) including all cause death,
stroke and TIA, myocardial infarction, thromboembolic events, bleeding, access
site infection, need for permanent pacemaker, pulmonary vein stenosis,
esophageal fistula, cardiac tamponade or pericardial effusion requiring
intervention.
Secondary outcome
Not Applicable
Background summary
AF currently affects approximately 2.2 million patients in the U.S. and is the
most common rhythm disorder among U.S. patients hospitalized with a primary
diagnosis of an arrhythmia The increased rates of morbidity and mortality
associated with AF demonstrate the need for an effective and reliable treatment
for AF. Additionally, the increased survival rates observed in mitral valve
repair patients who were previously suffering from AF suggest that restoring
NSR is associated with improved patient outcome.
Anti-arrhythmic drug (AAD) therapy remains the first line of treatment for AF;
however, it does not represent a cure for AF. All AAD therapies used for AF
treatment have significant side effects and they are of marginal effectiveness
in nearly all patient populations. Atrial pacing and defibrillators do not cure
the arrhythmia and may not result in better quality of life.
RF catheter ablation with creation of complex and extensive lesions in the left
atrium has resulted in variable rates of success in patients suffering from
persistent AF, but this can only be achieved with long procedure times and
extended fluoroscopy exposure for patients and medical staff.
As an alternative, an open heart Cox Maze procedure may be used to eliminate AF
by creating incisional scars to block abnormal electrical circuits that
maintain the arrhythmia. Success rates at 1 year are approximately 70% for
persistent AF and 80% for paroxysmal AF.
Study objective
The objective of the study is to demonstrate that the creation of cardiac
lesions with epicardially applied RF ablation through a minimally invasive
surgical (MIS) approach plus EP ablation performed when needed at least 3
months later enhances the efficacy of the treatment for persistent AF.
Study design
Prospective, multi-center, investigator-driven registry that will include
patients with a history of chronic AF who require thoracoscopic surgical
ablation due to clinical indications (corresponding to the study inclusion
criteria)..
This study hypothesizes that combining surgical endoscopic and transcatheter
techniques in a staged fashion provides superior clinical outcomes to isolated
surgical or EP approaches in patients with persistent AF lasting > 1 year but
<5 years.The surgical ablation procedure involves the creation of cardiac
lesions with epicardially applied radiofrequency (RF) ablation through a
minimally invasive surgical (MIS) approach. This procedure is performed
according to standard of care techniques for thoracoscopic ablation.
A delayed EP ablation procedure will be performed when needed after thethe
surgical ablation, according to the indications specified in the current
scientific consensus (2012 Guidelines*):
• Repeat ablation with an EP procedure is indicated in patients with recurrence
of AF after the index surgery. Since early recurrences of AF and/or the
development of atrial tachyarrythmias is common during the first two to three
months after AF ablation and may resolve spontaneously, the EP ablation will be
deferred for at least three months (blanking period) following the initial
surgical procedure; with the exception of patients who develop highly
symptomatic atrial arrhythmias that cannot be controlled with antiarrhythmic
therapy or slowed with rate controlling medications, who are best managed with
a reablation procedure within the first three months post surgical AF ablation.
• In addition, repeat EP ablation is recommended in patients who develop left
atrial flutter or tachycardia following surgical AF ablation; many of these
patients are highly symptomatic and their ventricular rate is difficult to
control, making the performance of another ablation procedure mandatory.
*2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical
Ablation of Atrial Fibrillation. Heart Rhythm, Vol 9, No 4, April 2012
Study burden and risks
All patients will be treated with state-of-the-art procedures using approved
CE-marked devices and techniques. The use of thoracoscopic ablation is known to
be safe and effective when used for the approved indications. The EP diagnostic
and ablation procedure and follow-up activities will be carried out in
accordance with approved diagnostic techniques and standard operating
procedures for the centers. Therefore, enrollment in this registry does not
pose undue risks to the patients. Because this study limits enrollment and is
being performed under a closely controlled protocol, the possible benefits
anticipated with the treatment administered far outweigh the potential risks.
Molengracht 21
Breda 4811RK
NL
Molengracht 21
Breda 4811RK
NL
Listed location countries
Age
Inclusion criteria
Symptomatic Recurrent Persistent AF or Long Standing Persistent AF, for > 1 year and < 5 years.
Documented effectiveness failure of at least one Class I or III AAD
Absence of LA thrombus by TEE, CT scan, MRI or angiography
Age 18-75 years
Written informed consent
Exclusion criteria
Documented left atrial size greater than 55 mm.
Documented LVEF of 40% or less.
History of cerebrovascular disease, including stroke or TIA within 6 months prior to enrollment
Previous heart surgery
COPD (70% predictive lung function)
Contraindication to anticaogulant therapy, or inability to comply with anticoagulation therapy
Pregnancy, planned pregnancy or breastfeeding
Concomitant cardiac surgery procedure planned.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46038.015.13 |