A First in Human Assessment of Safety and Performance of the Apama Radiofrequency (RF) Balloon Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillatio

Not Applicable

Completed

• Conditions: atrial fibrillation; paroxysmal atrial fibrillation; Cardiovascular - Other cardiovascular diseases; Surgery - Surgical techniques

• Registration Number: ACTRN12615001340527
• Lead Sponsor: Boston Scientific

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-08
• Study Completion: 2019-12-31
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

History of symptomatic paroxysmal and atrial fibrillation within the past year documented by ECG
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Safety assessed by the ability to deliver radiofrequency ablation with absence of device or procedure related serious adverse events following the procedure. Risks associated with this procedure are equal to those of other electrophysiological cardiac procedures including heart rhythm disturbances, blood clots, ischemic event. Transthoracic Echocardiography will be performed at discharge or 7 days post procedure whichever occurs first. [Echocardiography performed at 7 days post procedure ]

Secondary Outcome Measures

Name	Time	Method
Performance based on the clinical success of pulmonary vein isolation as defined by 12 lead ECG and Transthoracic Echo to confirm pulmonary vein isolation and confirmation of exit or block.[30 days post procedure]