N/A
N=5
Multipolar Mapping and Atrial Arrhythmias
Atrial Fibrillation or Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT02307188 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Atrial Fibrillation Dominant Frequency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Constellation Full Contact Mapping Catheter (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Angelo Biviano
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Fibrillation Dominant Frequency |
— | — |
Summary
This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.
Eligibility Criteria
Inclusion Criteria
Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment:
- Older than 45 years of age
- History of AF and/or AFL and are candidates for catheter ablation.
Exclusion Criteria
Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following:
- Permanent leads or prosthetic or stenotic valves present
- Active systemic infection
- Echocardiographically-confirmed visual presence of thrombus
- For whom the inability of obtaining vascular access exists
- Heparin-induced thrombocytopenia
- Hemodynamic instability or shock
Data sourced from ClinicalTrials.gov (NCT02307188). 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.