VICTORY AF evaluation of multielectrode phased RF technology in persistent Atrial Fibrilatio

Phase 4

Completed

• Conditions: atrial fibrillation- abnormal heart rhytm; 10007521

• Registration Number: NL-OMON40478
• Lead Sponsor: Medtronic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the safety is made up of the evaluation of the risk of<br /><br>procedure and / or device-related strokes, in subjects with persistent or<br /><br>long-term persistent atrial fibrillation (AF), which undergo an ablation with<br /><br>the phased RF system</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>nvt</p><br>