N/A
N=78
Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01581437 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Drivers in Right Atrial — 25.3 percentage of rotor sources
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 64 pole basket catheter (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Drivers in Right Atrial |
25.3 | — |
| PRIMARY Time to Ablation of All Sources |
16.6 | — |
| PRIMARY Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources |
50 | — |
| PRIMARY Average Number of Rotors/Focal Drivers in Diverse Locations |
2.3 | — |
| SECONDARY Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs |
78 | — |
| SECONDARY Mean Time to Recurrence of Atrial Fibrillation |
245 | — |
| SECONDARY Single-procedure Freedom From Atrial Fibrillation |
87.5 | — |
| SECONDARY Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation |
80.5 | — |
Summary
The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.
Eligibility Criteria
Inclusion Criteria
- Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
- Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
Exclusion Criteria
- Active coronary ischemic in the past year
- Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
- Prior ablation or cardiac surgery, that alters atrial electophysiology
- Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk
- Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1
- Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
- Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
- Pregnancy
- Inability or unwillingness to provide informed consent
- Unable to converse in English
- Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology
Data sourced from ClinicalTrials.gov (NCT01581437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.