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New treatment option for Atrial Fibrillation
Official title Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
ClinicalTrials.gov ID: NCT07271238
What this study is testing
- What it's testing
- The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- IC1: Subject is at least 18 years of age at the time of consent
- IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local...
- IC3: Subject is able to understand and willing to provide written informed consent
- IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
You likely can't join if
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non-...
- EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
- EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- EC6: Life expectancy less than 12 months
See the full eligibility criteria
- IC1: Subject is at least 18 years of age at the time of consent
- IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local guidelines and per physician discretion
- IC3: Subject is able to understand and willing to provide written informed consent
- IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the...
- EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
- EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- EC6: Life expectancy less than 12 months
- EC7: Current LA thrombus Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is...
- EC8: people who are currently enrolled in another study
The study team makes the final eligibility decision.
Where it's taking place
- Split, Croatia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Split, Croatia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.