Status
Conditions
Treatments
About
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
• History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
Exclusion criteria
• Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment:
New York Heart Association (NYHA) Class III or IV
Left ventricular ejection fraction (LVEF) <35%
Left atrial (LA) diameter >5.5 cm
Unstable angina or ongoing myocardial ischemia (OMI)
Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
Primary purpose
Allocation
Interventional model
Masking
62 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal