N/A
N=200
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
Typical Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT01408485 ↗Enrolled (actual)
200
Serious AEs
2.8%
Results posted
Jun 2014
Primary outcome: Primary: Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapy™ Cool Flex™ Irrigated Ablation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure |
5 | — |
| PRIMARY Primary Efficacy |
177 | — |
| SECONDARY Secondary Efficacy |
150 | — |
Summary
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
Eligibility Criteria
Inclusion Criteria
- A signed written Informed Consent
- Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply
- One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
- In good physical health
- 18 years of age or older
- Agree to comply with follow-up visits and evaluation
Exclusion Criteria
- Prior typical atrial flutter ablation treatment
- Pregnancy
- Atypical flutter or scar flutter (non isthmus dependent)
- Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
- A recent myocardial infarction within 3 months of the intended procedure date
- Permanent coronary sinus pacing lead
- Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
- Evidence of intra-cardiac thrombus or a history of clotting disorders
- Participation in another investigational study
- Cardiac surgery within 1 month prior to the intended procedure date
- Allergy or contraindication to Heparin
Data sourced from ClinicalTrials.gov (NCT01408485). 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.