Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2015-08-31
2018-08-31
Brief Summary
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Detailed Description
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Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities, complex fractionated atrial electrograms, consistent direction of wave front propagation, and low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies to target the evaluation of these characteristics and mechanisms responsible for the AF and left AT, identification of atrial areas with low peak-to-peak voltages and determination of the "critical" atrial targets for catheter ablation during the procedures would be essential.
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal AF or left AT.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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EnSite™ HD Grid Catheter AF/AT Mapping
EnSite™ HD Grid Catheter mapping system
Interventions
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EnSite™ HD Grid Catheter mapping system
Eligibility Criteria
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Inclusion Criteria
2. Age of 18 years of age or older at time of Enrollment
3. On continuous anticoagulation (INR 2-3) for \>4 weeks prior to the ablation
4. Able and willing to provide written informed consent to participate in this clinical investigation
Exclusion Criteria
2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
3. Active systemic infection (e.g. sepsis)
4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
6. History of cerebrovascular accidents (Stroke, TIA)
7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass \<180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment
8. Left atrial size \>55mm
9. NYHA (New York Heart Association Classification) functional class III or IV heart failure
10. Left ventricular ejection fraction \<35%
11. Uncontrolled Hyperthyroidism
12. Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
13. Participating in another clinical investigation that may confound the results of this clinical investigation
14. Life expectancy less than 12 months, as determined by Study Investigator
15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Carlo Pappone, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
San Donato Hospital, Italy
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
Ashford Hospital
Ashford, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Hôpital du Haut Lévêque
Pessac, , France
Herzzentrum Dresden GmbH Universitatsklinik
Dresden, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
San Donato Hospital
Milan, , Italy
Countries
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Other Identifiers
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CRD772
Identifier Type: -
Identifier Source: org_study_id
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