Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
Not Applicable
Terminated
- Conditions
- Atrial Flutter
- Interventions
- Device: Cardiac Ablation (Gen2 Cardiac Ablation System)
- Registration Number
- NCT00606463
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Irrigated catheter for ablation of isthmus-dependent atrial flutter
- Detailed Description
This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Scheduled for ablation of isthmus-dependent atrial flutter
Exclusion Criteria
- Prior ablation of isthmus-dependent atrial flutter
- Atypical or scar flutter
- Significant heart disease
- Intracardiac thrombus
- Prior cardiac surgery (within 1 month)
- Contraindication to heparin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description (Gen2 Cardiac Ablation System) Cardiac Ablation (Gen2 Cardiac Ablation System) Ablation of isthmus-dependent atrial flutter
- Primary Outcome Measures
Name Time Method Incidence of intraprocedural, serious cardiac adverse event 7 days post-procedure Defined as the Incidence of intraprocedural, serious cardiac adverse event
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie irrigated radiofrequency ablation efficacy in NCT00606463 isthmus-dependent atrial flutter?
How does the Gen2 irrigated catheter compare to standard-of-care ablation techniques for atrial flutter in terms of procedural outcomes?
Which biomarkers correlate with successful isthmus ablation using the Gen2 system in patients with typical atrial flutter?
What adverse events were reported in NCT00606463 and how do they align with Abbott's Gen2 catheter safety profiles in arrhythmia trials?
Are there combination therapies or alternative ablation systems (e.g., cryoablation) that enhance atrial flutter treatment outcomes compared to Gen2?
Trial Locations
- Locations (3)
St. Barnabus Medical Center
🇺🇸West Orange, New Jersey, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States