Demonstrate that the observed incidence of procedure and/or device related incidence of new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure (index or reablation) with the Phased RF System is less than 1.8% with…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the safety is made up of the evaluation of the risk of
procedure and / or device-related strokes, in subjects with persistent or
long-term persistent atrial fibrillation (AF), which undergo an ablation with
the phased RF system
Secondary outcome
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Background summary
Atrial fibrillation is a debilitating disease with symptoms that reduce quality
of life and put subjects at a higher risk of stroke than subjects with no
atrial fibrillation.
Current treatment options include antiarrhythmic drug therapy, catheter
ablation for paroxysmal atrial fibrillation and concomitant surgical therapy.
These treatment options have poor effectiveness outcomes and carry side effects
from antiarrhythmic drugs and procedural risks from the surgical therapies.
Currently in the U.S. catheter ablation is not indicated for the treatment of
persistent and long standing persistent (herein referred to as persistent)
atrial fibrillation and therefore subjects that have failed antiarrhythmic drug
therapy and are not candidates or have failed surgical therapies have no other
FDA approved treatment options.
Previous to this proposed study, the tailored treatment for permanent atrial
fibrillation (TTOPAF) study was conducted to demonstrate the safety and
effectiveness the Phased RF system.
TTOP-AF was conducted between 2007 and 2010 and presented to the FDA
Circulatory System Devices Panel on October 27, 2011.
Based on the TTOP-AF data the panel voted that the Phased RF system was
effective in the treatment of subjects with persistent atrial fibrillation.
However, the panel was concerned with the peri-procedural stroke rate and
pulmonary vein stenosis rates.
Therefore the panel voted that the benefits of the Phased RF system did not
outweigh the risks of treating subjects with persistent atrial fibrillation.
Thus, Medtronic with the agreement of the FDA is conducting this study to
demonstrate that the Phased RF system is safe after the implementation of
mitigation strategies to lower the periprocedural stroke rate (i.e.
anticoagulation and catheter programming requirements). Therefore, the primary
objective of the study is to confirm the safety of the Phased RF system and not
to evaluate the system*s effectiveness.
Study objective
Demonstrate that the observed incidence of procedure and/or device related
incidence of new stroke (excludes transient ischemic attack) within 30 days of
an ablation procedure (index or reablation) with the Phased RF System is less
than 1.8% with observed upper confidence boundary that is less than 3.5%.
The definition of stroke is provided in the Table 5 in the protocol pag. 20
Primary study objective
* 30-day procedure and/or device related stroke rate
Secondary study objectives
* 6-month post-procedural effectiveness
* Acute procedural success
* Pulmonary vein stenosis (PVS)
Ancillary study objectives
* Single procedural effectiveness
* 6-month reduction in AF burden
* Post-procedural asymptomatic cerebral embolism (ACE) rate
* Peri-procedural serious adverse events
* Peri-procedural stroke and transient ischemic attack (TIA)
* Summarize adverse events
Study design
This study is a prospective, unblinded, multi-center, investigational (U.S. and
Canada), global, clinical study designed to evaluate the procedure and/or
device related stroke rate within 30 days of an ablation procedure with the
Medtronic Phased RF System. In regions where the system is market released, the
system will be used in the manner for which it was intended.
The primary safety objective will be evaluated after at least 300 ablated
subjects complete the 30 day post index or reablation procedure visit and have
had the opportunity for a reablation visit. The study may stop early for
futility if more than six (6) procedure and/or device related
strokes occur prior to completing enrollment.
Intervention
100 subject will be submitted to a subgroup ACE, these subjects will have 3x a
brainscan. For 100 subjects whom will submitted to the subgroup PVS these
subjects will undergo 2x a thoracic scan. All subjects will have a TEE, and
anticoagulant medicines.
Study burden and risks
Based on the current knowledge, participation into het Victory AF, does noet
impose additional risks. The potential benefits of the study outweigh
thepotential risks; therefore he investigation is jusified. It is possible in
any clinical trial that harmful things can happen which are not know at this
time. All efforts will be made to minimze the risks in this study by selecting
investigators who are experienced and trained in the use of the study device
and trained to the study portocol, by clearly defining inclusion/exclusion
criteria to ensure only appropariate subjects are inrolled, and by ensuring
that treatment and follow-up of the subject are consistent with current medical
practices.
Prins Clausplein 105
Leeuwarden 8935DE
NL
Prins Clausplein 105
Leeuwarden 8935DE
NL
Listed location countries
Age
Inclusion criteria
* History of symptomatic persistent or long-standing persistent atrial fibrillation defined as:
o Persistent AF: sustained AF lasting > 7 days and less than one year, or lasting <
7 days but necessitating pharmacologic or electrical cardioversion; OR
o Long-standing persistent AF: sustained AF lasting at least 1 year, but no more
than 4 years in duration.
o Continuous AF as demonstrated on a 48-hour Holter at baseline
o AF symptoms defined as the manifestation of:
* Palpitations
* Fatigue
* Exertional dyspnea
* Increased intolerance to routine activities (exercise intolerance)
* Age between 18 and 70
* Failure of at least one class I or III rhythm control AAD
Exclusion criteria
Structural heart disease of clinical significance including:
o Previous cardiac surgery other than CABG or mitral valve repair
o NYHA Class III or IV CHF and/or documented ejection fraction <40%
measured by acceptable cardiac testing
o Left atrial diameter of >55mm
o Moderate to severe mitral or aortic valvular heart disease
o Stable/unstable angina or ongoing myocardial ischemia
o Myocardial infarction (MI) within three months of enrollment
o Congenital heart disease other than ASD or PFO without a right to left shunt
where the underlying abnormality increases the risk of an ablative procedure
o Prior ASD or PFO closure with a device using a percutaneous approach
o Hypertrophic cardiomyopathy (LV septal wall thickness >1.5 cm)
o Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler
echo)
* Any prior ablation for atrial fibrillation in the left atrium
* Enrollment in any other ongoing arrhythmia study protocol
* Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the
management may interfere with this study
* Active infection or sepsis
* Any history of cerebral vascular disease including stroke or TIAs
* Pregnancy or lactation
* Left atrial thrombus at the time of ablation
* Untreatable allergy to contrast media
* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or vitamin K antagonists (ie. Warfarin/Coumadin)
* Prescribed to direct thrombin or factor inhibitors
* Severe COPD (defined as an FEV1 <1)
* Severe co-morbidity or poor general physical/mental health that, in the opinion of the
Investigator, will not allow the subject to be a good study candidate (i.e. other disease
processes, mental capacity, substance abuse, shortened life expectance, etc.)
* MRI contraindicated
* Any invasive cardiovascular procedure performed or planned within the 3 month period
prior to the ablation procedure
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 |
|---|---|
| ClinicalTrials.gov | NCT01693120 |
| CCMO | NL44784.060.13 |