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A feasibility study to characterize electrograms in patients undergoing atrial fibrillation ablation

A Feasibility Pilot Study to Characterize Baseline Atrial Electrograms in Areas Targeted for Cather Ablation in Patients with Atrial Fibrillation Using the NavX System

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000313235
Acronym
NavX PVI
Enrollment
20
Registered
2009-05-21
Start date
2009-03-01
Completion date
Unknown
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

This study will use a different ablation technique that involves creating a three dimensional map of the electrical activity of the heart, followed by identification and ablation of the areas of abnormal activity. It is hypothesized that this technique is feasible and effective and will achieve pulmonary vein antrum isolation, while lowering exposure to fluoroscopy.

Interventions

A map of fractionated potentials will be used during an atrial fibrillation (AF) ablation to define the area typically ablated during pulmonary vein antrum isolation using the Diagnostic Landmark Map. The procedure will take no more than 30 minutes.

Sponsors

St Jude Medical
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

-Any patient with atrial fibrillation requiring ablation -able to achieve and maintain stable sinus rhythm during the mapping procedure -be on therapeutic level of anticoagulation as determined by the physician

Exclusion criteria

-Patients with left atrial thrombus or heavy echo contrast on trans-esophageal echo (TEE) prior to the procedure as per physician discretion and standard of care -Chronic atrial fibrillation - Inadequate anticoagulation as defined in the inclusion criteria. -Significant underlying pulmonary disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026