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
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: TactiCath SE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation|
|Actual Study Start Date :||December 11, 2017|
|Actual Primary Completion Date :||August 2, 2018|
|Actual Study Completion Date :||October 30, 2019|
Experimental: TactiCath SE
Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.
Device: TactiCath SE
Ablation to achieve pulmonary vein isolation.
- Rate of Serious Adverse Events [ Time Frame: 30 days ]
The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are:
- Atrial-esophageal fistula
- AV block
- Cardiac Perforation/ Tamponade
- Diaphragmatic paralysis
- Myocardial Infarction
- Pulmonary edema
- Pulmonary vein stenosis
- Transient ischemic attack
- Vascular access complications
Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint.
- Number of Participants With Procedural Success [ Time Frame: 0 days ]The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
- Average Power Delivered [ Time Frame: During Procedure ]This outcome is the average power delivered for a case.
- Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force [ Time Frame: 0 days ]Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
- Number of Participants Experiencing Serious Adverse Events Within 30 Days [ Time Frame: 30 days ]Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.
- Number of Participants Experiencing a Serious Adverse Event Within 1 Year [ Time Frame: 1 year ]Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
- One-year Freedom From AF [ Time Frame: 1 year ]One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.
- One-year Drug-free Success From AF [ Time Frame: 1 year ]One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.
- Changes in EQ-5D-5L Utility Scores [ Time Frame: 1 year ]Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.
- Changes in AFEQT Scores [ Time Frame: 1 year ]Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.
- Health Care Utilization [ Time Frame: 1 year ]Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.
- Force Time Integral (FTI) [ Time Frame: 0 days ]Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.
- Average Catheter Temperature [ Time Frame: 0 days ]This outcome is the average temperature (by lesion) for a case.
- Number of Participants With Recommended Irrigation Flow Rate Used During Procedure [ Time Frame: 0 days ]This outcome is whether or not the recommended irrigation flow rate was used for a case.
- Contact Force During Procedure [ Time Frame: 0 days ]This outcome is the average contact force for a case.
- Total Procedure Time [ Time Frame: 0 days ]This outcome is the total procedure time for a case.
- Ablation Time - First to Last Ablation [ Time Frame: 0 Days ]This outcome is the total ablation time for a case. This is the time from first to last ablation.
- Fluoroscopy Time [ Time Frame: 0 days ]This outcome is the total fluoroscopy time for a case.
- Radiofrequency (RF) Application Time [ Time Frame: 0 days ]This outcome is the total RF application time for a case.
- Number of Participants Using AutoMark [ Time Frame: 0 days ]This outcome is the number of cases using AutoMark.
- Lesion Index (LSI) [ Time Frame: 0 days ]
Mean lesion index (LSI) across lesions by subject
Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.
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): NCT03354663
|Study Director:||Kristin Ruffner, PhD MBA||Abbott|