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Safety Study of the .AlCath Force catheter in patients with atrial arrhythmias

Safety of the AlCath Force catheter during radiofrequency ablation in patients with atrial fibrillation or atrial flutter

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000763448
Enrollment
30
Registered
2016-06-09
Start date
2016-07-01
Completion date
2016-07-29
Last updated
2020-01-13

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 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 thre

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

BIOTRONIK Australia Pty. Ltd.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026