Phase 4
N=291
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT00318565 ↗Enrolled (actual)
291
Serious AEs
1.5%
Results posted
Mar 2010
Primary outcome: Primary: Percentage of Subjects With Complete Bidirectional Conduction Block. — 93.3 percentage of participants — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RF energy delivery for treatment of Typical Atrial flutter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biosense Webster, Inc.
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Complete Bidirectional Conduction Block. |
93.3 | .05 |
| PRIMARY Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. |
1.5 | .05 |
Summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Eligibility Criteria
Inclusion Criteria
- Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- 18 years of age or older
- Informed consent
Exclusion Criteria
- Intracardiac thrombus
- Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
- Women who are pregnant
- Cardiac surgery (ventriculotomy or atriotomy) within the past two months
- Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
- Unstable angina or acute myocardial infarction within 3 months
- Awaiting cardiac transplantation
- Heart disease in which corrective surgery is anticipated within 6 months
- Presence of condition that precludes appropriate vascular access
- Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
- High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
- Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Data sourced from ClinicalTrials.gov (NCT00318565). 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.