TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (TactiSense)
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ClinicalTrials.gov Identifier: NCT03354663 |
Recruitment Status :
Completed
First Posted : November 28, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 7, 2020
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Paroxysmal Atrial Fibrillation |
Intervention |
Device: TactiCath SE |
Enrollment | 156 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | TactiCath SE |
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Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. |
Period Title: Enrollment to Catheter Insertion | |
Started | 156 |
Completed | 151 |
Not Completed | 5 |
Reason Not Completed | |
Did not meet inc/exc criteria | 4 |
Adverse Event | 1 |
Period Title: Completed 30-day Visit | |
Started | 151 |
Completed | 149 |
Not Completed | 2 |
Reason Not Completed | |
Withdrawal by Subject | 1 |
Missed Visit | 1 |
Baseline Characteristics
Arm/Group Title | TactiCath SE | |
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Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. |
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Overall Number of Baseline Participants | 151 | |
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Population includes all subjects with device inserted into vasculature.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
75 49.7%
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>=65 years |
76 50.3%
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 151 participants | |
65.0
(56.0 to 71.0)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
Female |
60 39.7%
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Male |
91 60.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
Hispanic or Latino |
3 2.0%
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Not Hispanic or Latino |
125 82.8%
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Unknown or Not Reported |
23 15.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
American Indian or Alaska Native |
1 0.7%
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Asian |
2 1.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
1 0.7%
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White |
123 81.5%
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More than one race |
3 2.0%
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Unknown or Not Reported |
21 13.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 151 participants |
United States | 101 | |
Italy | 12 | |
Australia | 22 | |
Germany | 21 | |
BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 151 participants | |
28.0 (5.0) | ||
Coronary Artery Disease
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
20 13.2%
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Heart Failure
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
4 2.6%
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Hypertension
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
80 53.0%
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Diabetes
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
15 9.9%
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Stoke/Transient Ischemic Attack
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
14 9.3%
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Myocardial Infarction
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
6 4.0%
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Obstructive Sleep Apnea
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
20 13.2%
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Structural Heart Disease
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
5 3.3%
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Known Family History of Cardiovascular Disease
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
81 53.6%
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Left Ventricular Ejection Fraction
Median (Inter-Quartile Range) Unit of measure: % |
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Number Analyzed | 151 participants | |
60.7
(55.0 to 65.0)
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Left Atrium Diameter
Median (Inter-Quartile Range) Unit of measure: Centimeters |
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Number Analyzed | 151 participants | |
3.8
(3.3 to 4.3)
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Pacemaker or Implantable Cardiac Monitor
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | |
19 12.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Steven Madej |
Organization: | Abbott |
Phone: | 651-756-2230 |
EMail: | steven.madej@abbott.com |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT03354663 |
Other Study ID Numbers: |
SJM-CIP-10216 |
First Submitted: | November 17, 2017 |
First Posted: | November 28, 2017 |
Results First Submitted: | August 1, 2019 |
Results First Posted: | August 20, 2019 |
Last Update Posted: | August 7, 2020 |