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 Fibrillation

• Register: ANZCTR
• Last refreshed on: 22 November 2021
• Main ID: ACTRN12615001340527
• Date of registration: 08/12/2015
• Prospective Registration: Yes
• Primary sponsor: Boston Scientific
• Public title: 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 Fibrillation
• Scientific title: A First In Human Radiofrequency (RF) Balloon Catheter Ablation to Isolate Pulmonary Veins in the Treatment of Patients with Paroxysmal Atrial Fibrillation
• Date of first enrolment: 08/03/2016
• Target sample size: 125
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001340527.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety;
• Phase: Not Applicable

Countries of recruitment

Czech Republic, Lithuania, New Zealand, Paraguay

Contacts

• Name: Ms Allison Anderson

• Name: Ms Allison Anderson

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Other cardiovascular diseases

atrial fibrillation;paroxysmal atrial fibrillation;
atrial fibrillation
paroxysmal atrial fibrillation

Surgery - Surgical techniques

Intervention(s)

Apama RF Balloon Catheter system used for radiofrequency ablation; RF energy administered to tissue at 8-10 Watts power over durations of 60 - 90 seconds with irrigation of 30 ml/minute. 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.

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Apama Medical

Ethics review

Status: Approved
Approval date: 11/11/2015
Contact:

Health and Disability Ethics Committees

Results

• Results available: Yes
• Date Posted: 17/02/2020
• Date Completed: 31/12/2019