Medtronic Evaluation of Multi-Electrode Phased RF Technology in Persistent Atrial Fibrillation

Recruiting
1 years - 99 years
All
Phase
3
1 participants needed
1 Location
Brief description of study
The study is expected to be conducted at approximately 40 centers located in Europe, Canada
and the United States to support US Food and Drug Administration (FDA) marketing
application. A maximum of 350 subjects will be enrolled in the study to ensure 300 subjects
can be evaluated for the primary safety endpoint. Subjects will be followed for 30 days post
reablation (if reablation required) procedure or 6 months post index procedure (if no reablation
procedure required) for the primary safety objective. 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. Alternatively, the study may
stop early for futility if more than 6 procedure and/or device related strokes occur within the 30
day peri-procedural period prior to completing enrollment.
Study subjects from all geographies will be followed for 6 months following their final ablation
procedure, or official study closure defined as when Medtronic and/or regulatory requirements
have been satisfied per the Clinical Investigational Plan (CIP), whichever occurs first.
Accordingly, the expected total study duration is approximately 36 months, representing 24
months of enrollment and up to 12 months of subject follow-up..
The Medtronic Phased RF System is intended to be used for mapping intracardiac electrograms
and to deliver precise, temperature controlled radio frequency (RF) ablation therapy within the
left atrium of the heart for the treatment of atrial fibrillation. The Phased RF System includes the
GENius Multi Channel Radio Frequency Ablation Generator and three anatomically designed,
multi-electrode catheters:
Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD)
Multi-Array Septal Catheter (MASC)
Multi-Array Ablation Catheter (MAAC)
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
Willingness, ability and commitment to participate in baseline and follow-up evaluations
for the full length of the study
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 3+ 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 imba
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Atrial Fibrillation
-
Age: 1 years - 99 years
-
Gender: All
Updated on
19 Feb 2024.
Study ID: 818673