|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02656537 |
|
Date of registration:
|
16/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
EnSite™ HD Grid Catheter AF/AT Mapping Study
|
|
Scientific title:
|
EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
82 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02656537 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Australia
|
France
|
Germany
|
Hong Kong
|
Italy
| | | |
|
Contacts
|
|
Name:
|
Carlo Pappone, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
San Donato Hospital, Italy |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT)
referred for catheter ablation
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:
1. Secondary atrial fibrillation (AF)
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Non-paroxysmal Atrial Fibrillation
|
|
Left Atrial Tachycardia
|
|
Intervention(s)
|
|
Device: EnSite™ HD Grid Catheter mapping system
|
|
Primary Outcome(s)
|
|
Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system.
[Time Frame: During Procedure]
|
|
Catheter performance during the mapping portion of the procedure
[Time Frame: During Procedure]
|
|
Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.
[Time Frame: Within 48 hours from Procedure]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|