Assessment of Safety and Performance of the Radio Frequency Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillation Control Study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000509167

Acronym

AF-FICIENT Control

Enrollment

Registered

2019-03-29

Start date

2019-07-22

Completion date

2020-03-04

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The AF-FICIENT Control study is a prospective, non-randomized, single center, single arm study. The objective of the study is to collect brain MRI data specific to asymptomatic cerebral events (ACE) for commercially available RF catheters in patients indicated for ablation treatment for de-novo paroxysmal atrial fibrillation (PAF).

Interventions

Radiofrequency (RF) ablation. Procedural times can vary from one hour to approximately three hours depending upon the ability to isolate veins using radiofrequency and to restore rhythm to normal sinus. Subjects will also undergo a brain MRI before and after the ablation procedure. Radiofrequency ablation should be used within the device directions for use (generally a range of in the range of 350–500 kHz).

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

History of symptomatic, documented paroxysmal atrial fibrillation Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation

Exclusion criteria

Structural heart disease of clinical significance including previous cardiac surgery (excluding CABG or mitral valve repair) Documented EF <30% Left atrial diameter of >55mm Contraindication to anticoagulation therapy Unstable angina or ongoing myocardial ischemia Myocardial infarction within 3 months of enrollment Congenital heart disease where the underlying abnormality increases the risk of the ablation Prior Atrial Septal Defect or Patent Foramen Ovale Closure with a device using a transcatheter percutaneous approach Hypertrophic cardiomyopathy (LV septal wall thickness >1.5cm) Pulmonary hypertension (>50mm Hg) Prior ablation for atrial fibrillation Enrollment in any other ongoing arrhythmia study protocol Patients with severely impaired kidney function as measured by Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29 Active gastrointestinal bleeding, infection or fever (>100.5/38C) or sepsis Short life expectancy (<1 year) due to illness such as cancer, pulmonary,hepatic or renal disease Significant anemia (hemoglobin < 8.0 / dl) Severe uncontrolled systemic hypertension with systolic >200mm Hg within ast 30 days Documented anaphylaxis during previous exposure to contrast media Bleeding or clotting disorders or thrombotic disorder under treatment Uncontrolled diabetes Women who are pregnant and not willing to use contraception for the duration of the study Severe COPD (identified by an FEV1 <1) Unwilling or unable to comply with any protocol or follow up requirements

Outcome results