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Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650556
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : April 27, 2022
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Persistent Atrial Fibrillation
Intervention Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Enrollment 224
Recruitment Details A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Pre-assignment Details One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.
Arm/Group Title Enrolled
Hide Arm/Group Description A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Period Title: Overall Study
Started 224
Ablation Procedure 223
Pre-Discharge 223
7-day Follow-Up 223
3-month Follow-Up 210
6-month Follow-up 197
12-month Follow-Up 189
15-month Follow-Up 187
Completed 187
Not Completed 37
Reason Not Completed
Death             2
Withdrawal by Subject             20
Physician Decision             2
Lost to Follow-up             8
Subject did not complete follow-up but did not meet criteria for lost-to-follow-up             4
Enrolled, but no ablation performed-investigational catheter was not inserted             1
Arm/Group Title Ablation
Hide Arm/Group Description All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
Overall Number of Baseline Participants 223
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants
65.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
Female
69
  30.9%
Male
154
  69.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
Hispanic or Latino
3
   1.3%
Not Hispanic or Latino
209
  93.7%
Unknown or Not Reported
11
   4.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.4%
Black or African American
6
   2.7%
White
213
  95.5%
More than one race
0
   0.0%
Unknown or Not Reported
3
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
United States
209
  93.7%
Australia
14
   6.3%
1.Primary Outcome
Title Rate of Subjects With a Device and/or Procedure-related SAE.
Hide Description Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
Time Frame Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for the primary safety endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event
Arm/Group Title Enrolled
Hide Arm/Group Description:
A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Overall Number of Participants Analyzed 223
Measure Type: Count of Participants
Unit of Measure: Participants
7
   3.1%
2.Primary Outcome
Title Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
Hide Description

The following events were considered a failure for AF/AFL/AT recurrence:

  • If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or
  • If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or
  • If the subject required a second repeat procedure at any time after the initial procedure, or
  • If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or
  • If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or
  • If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for the primary effectiveness endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
Arm/Group Title Enrolled
Hide Arm/Group Description:
A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Overall Number of Participants Analyzed 190
Measure Type: Count of Participants
Unit of Measure: Participants
114
  60.0%
3.Secondary Outcome
Title Acute Procedural Success
Hide Description Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
Time Frame Immediate post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
Arm/Group Title Enrolled
Hide Arm/Group Description:
A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Overall Number of Participants Analyzed 223
Measure Type: Count of Participants
Unit of Measure: Participants
219
  98.2%
4.Secondary Outcome
Title 15-month Success Off of Antiarrhythmic Drugs
Hide Description Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
Arm/Group Title Ablation
Hide Arm/Group Description:

Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™: Ablation procedure for Persistent AF

Overall Number of Participants Analyzed 190
Measure Type: Count of Participants
Unit of Measure: Participants
89
  46.8%
5.Secondary Outcome
Title 15 Month Single Procedure Success
Hide Description Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
Arm/Group Title Ablation
Hide Arm/Group Description:

Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™: Ablation procedure for Persistent AF

Overall Number of Participants Analyzed 190
Measure Type: Count of Participants
Unit of Measure: Participants
110
  57.9%
Time Frame 15 months
Adverse Event Reporting Description An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
 
Arm/Group Title Enrolled
Hide Arm/Group Description A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
All-Cause Mortality
Enrolled
Affected / at Risk (%)
Total   2/224 (0.89%)    
Hide Serious Adverse Events
Enrolled
Affected / at Risk (%) # Events
Total   59/224 (26.34%)    
Cardiac disorders   
Arrhythmia *  9/224 (4.02%)  9
Coronary Artery Thrombosis/Occlusion *  1/224 (0.45%)  1
Heart Failure/Pump Failure *  3/224 (1.34%)  3
Valve Insufficiency *  1/224 (0.45%)  1
Bradycardia *  1/224 (0.45%)  1
Sick Sinus Symptom *  1/224 (0.45%)  1
Sinus Bradycardia *  1/224 (0.45%)  1
Chest Pain/Discomfort *  8/224 (3.57%)  8
Cardiac Perforation or Tamponade *  1/224 (0.45%)  1
Pericardial Effusion *  3/224 (1.34%)  3
Gastrointestinal disorders   
Acute Ischemic Colitis *  1/224 (0.45%)  1
Bowel Obstruction *  1/224 (0.45%)  1
Cholecystitis *  1/224 (0.45%)  1
Colon Obstruction *  1/224 (0.45%)  1
Lower GI Bleed *  2/224 (0.89%)  2
Gastroparesis *  1/224 (0.45%)  1
Colitis *  1/224 (0.45%)  1
General disorders   
Elective Procedure/Surgery *  5/224 (2.23%)  5
Syncope/Dizziness *  1/224 (0.45%)  1
Collapse *  1/224 (0.45%)  1
Rectal and Vaginal Prolapse Repair *  1/224 (0.45%)  1
Sudden Cardiac Death *  1/224 (0.45%)  1
Trauma *  1/224 (0.45%)  1
Jaw and Neck Pain *  1/224 (0.45%)  1
Immune system disorders   
Allergic Reaction *  1/224 (0.45%)  1
Infections and infestations   
Infection *  4/224 (1.79%)  4
Pelvic Inflammatory Disease *  1/224 (0.45%)  1
Urosepsis *  1/224 (0.45%)  1
Pneumonia *  1/224 (0.45%)  1
Musculoskeletal and connective tissue disorders   
Fracture of Humerous *  1/224 (0.45%)  1
Right Hip Fracture *  1/224 (0.45%)  1
Nervous system disorders   
Cerebrovascular Accident/Stroke *  2/224 (0.89%)  3
Psychiatric disorders   
Encephalopathy *  1/224 (0.45%)  1
Renal and urinary disorders   
Renal Decompensation/Acute Kidney Injury *  1/224 (0.45%)  1
Urinary Retention *  1/224 (0.45%)  1
Reproductive system and breast disorders   
Penile Fracture *  1/224 (0.45%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Edema *  1/224 (0.45%)  1
Respiratory Compromise/Decompensation *  2/224 (0.89%)  2
Dyspnea *  1/224 (0.45%)  1
Tracheobronchitis *  1/224 (0.45%)  1
Vascular disorders   
Bleeding/Anemia *  5/224 (2.23%)  5
Hypertension *  1/224 (0.45%)  1
Shock *  1/224 (0.45%)  1
Volume Overload *  3/224 (1.34%)  3
Hypotension *  1/224 (0.45%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled
Affected / at Risk (%) # Events
Total   29/224 (12.95%)    
Blood and lymphatic system disorders   
Thrombosis/Thrombus *  1/224 (0.45%)  1
Elevated Troponin *  1/224 (0.45%)  1
Trochanteric Bursitis *  1/224 (0.45%)  1
Cardiac disorders   
Arrhythmia *  1/224 (0.45%)  1
Chest Pain/Discomfort *  5/224 (2.23%)  5
Pericardial Effusion *  2/224 (0.89%)  2
Pericarditis *  1/224 (0.45%)  1
Congestive Heart Failure *  1/224 (0.45%)  1
Gastrointestinal disorders   
Esophageal Inflammation *  1/224 (0.45%)  1
General disorders   
Transient Ischemic Attack *  1/224 (0.45%)  1
Cough *  2/224 (0.89%)  2
Fluid Retention *  1/224 (0.45%)  1
Headache *  2/224 (0.89%)  2
Jaw Pain *  1/224 (0.45%)  1
Hepatobiliary disorders   
Hepatohepatomegaly With Elevated Liver Enzymes *  1/224 (0.45%)  1
Infections and infestations   
Infection *  1/224 (0.45%)  1
Injury, poisoning and procedural complications   
Air Embolism *  1/224 (0.45%)  1
Musculoskeletal and connective tissue disorders   
Shoulder Blade/ Arm Pit Pain *  1/224 (0.45%)  1
Renal and urinary disorders   
Urinary Retention *  1/224 (0.45%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion *  1/224 (0.45%)  1
Vascular disorders   
Vascular Access Complication *  2/224 (0.89%)  2
Vascular Bleeding/Local Hematoma/Ecchymosis *  5/224 (2.23%)  5
Volume Overload *  3/224 (1.34%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amber Miller
Organization: Abbott Medical
Phone: (612) 413-7236
EMail: amber.miller@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03650556    
Other Study ID Numbers: ABT-CIP-10239
First Submitted: August 1, 2018
First Posted: August 28, 2018
Results First Submitted: January 18, 2022
Results First Posted: April 27, 2022
Last Update Posted: April 27, 2022