Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
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| ClinicalTrials.gov Identifier: NCT00984204 |
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Recruitment Status :
Completed
First Posted : September 25, 2009
Results First Posted : December 20, 2013
Last Update Posted : February 19, 2019
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Brief Summary:
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Typical Atrial Flutter | Device: Therapy Cool Path Duo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 188 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL) |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | August 2010 |
| Actual Study Completion Date : | January 2012 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment arm |
Device: Therapy Cool Path Duo
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter. |
Primary Outcome Measures :
- Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. [ Time Frame: 7 days ]
- Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained. [ Time Frame: 30 mins ]
Secondary Outcome Measures :
- Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure [ Time Frame: 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A signed written Informed Consent
- Presence of typical atrial flutter (cavotricuspid isthmus dependent)
- If subjects are receiving antiarrhythmic 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
- Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
- Evidence of intracardiac thrombus or a history of clotting disorders
- Participation in another investigational study
- Cardiac surgery within 1 month of the intended procedure date
- Allergy or contraindication to Heparin
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984204
Locations
Show 22 study locations
Sponsors and Collaborators
Abbott Medical Devices
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT00984204 |
| Other Study ID Numbers: |
90030638 |
| First Posted: | September 25, 2009 Key Record Dates |
| Results First Posted: | December 20, 2013 |
| Last Update Posted: | February 19, 2019 |
| Last Verified: | February 2019 |
Keywords provided by Abbott Medical Devices:
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cavo-tricuspid dependent |
Additional relevant MeSH terms:
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Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |