None listed
Conditions
Brief summary
The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the AlCath Force ablation catheter and the Qubic Force device. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.
Interventions
Catheter ablation is an atrial fibrillation treatment that is done by a specialized cardiologist, called an electrophysiologist (EP), who deals with irregular heartbeats (arrhythmias). It is a minimally-invasive procedure that is generally less invasive than surgery. It is a commonly-used treatment for atrial fibrillation as well as other cardiac arrhythmias. It is done on a beating heart in a closed chest procedure. Small punctures are made in the groin and the catheters, are inserted and threaded to the heart. Once there, the catheter's tip is threaded through a tiny incision in the wall between the left and right atria (septal wall), and is positioned to ablate tissue around the pulmonary veins or at other sources of erratic electrical signals that cause the irregular heartbeat. In case of atrial flutter, the catheter is used in the right atrium to electrically isolate the cavotricuspid isthmus which is a known pathway for atrial flutter waves. The catheter uses an energy source, such as radio frequency energy (radio waves) to create a lesion of scar tissue, called a conduction block, that stops the erratic electrical signals from travelling through the heart. The procedure usually takes around 2 to 4 hours per patient. The AlCath Force catheter which is used in this study is an irrigated radio frequency ablation catheter with contact force (CF) sensing capability. The catheter is connected to the Qubic Force device which derives the CF information from the signal received from the catheter.
Sponsors
Study design
Eligibility
Inclusion criteria
Paroxysmal AF with indication and consideration for pulmonary vein isolation (PVI) and/or atrial flutter with indication and consideration for cavotricuspid isthmus ablation legal capacity and ability to consent
Exclusion criteria
Any contraindications for ablation therapy Plan to combine the study procedure with any other cardiac intervention Previous atrial ablation Prior ischemic stroke or transient ischemic attack Pregnancy or breast feeding Participation in another interventional clinical investigation