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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03650556
• Collaborator: (none)
• Enrollment: 224
• Locations: 22
• Arm: 1
• Actual Duration (Months): 27.5
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Condition or Disease	Intervention/Treatment	Phase
Persistent Atrial Fibrillation	Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
• Actual Study Start Date: Sep 28, 2018
• Actual Primary Completion Date: Dec 21, 2020
• Actual Study Completion Date: Jan 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ablation Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).	Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™; Ablation procedure for Persistent AF

Outcome Measures

Primary Outcome Measures

1. Rate of Subjects With a Device and/or Procedure-related SAE. [Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure]

   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.

2. Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. [15 months]

   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

Secondary Outcome Measures

1. Acute Procedural Success [Immediate post procedure]

   Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins

2. 15-month Success Off of Antiarrhythmic Drugs [15 months]

   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.

3. 15 Month Single Procedure Success [15 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient must provide written informed consent prior to any clinical investigation related procedure.

2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF

3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF

4. Age 18 years or older

5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

1. Continuous AF > 12 months (longstanding persistent AF)

2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar

3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure

4. CABG surgery within the 6-months (180-days) prior to the initial procedure

5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)

6. Any carotid stenting or endarterectomy

7. Documented or known left atrial thrombus on imaging

8. Left atrial diameter > 50 mm (parasternal long axis view or by CT)

9. Left ventricular ejection fraction < 40%

10. Unable to take anticoagulation medication due to contraindication or intolerance

11. History of blood clotting or bleeding abnormalities

12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure

13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure

14. Rheumatic heart disease

15. Uncontrolled heart failure or NYHA functional class III or IV

16. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)

17. Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365 days) following the initial ablation procedure

18. Unstable angina at the time of the initial procedure

19. Acute illness or active systemic infection or sepsis

20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause

21. Diagnosed atrial myxoma

22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)

23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms

24. Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results

25. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period

26. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure

27. Presence of any condition that precludes appropriate vascular access or manipulation of catheter

28. Life expectancy less than 12-months

29. Body mass index > 40 kg/m2

30. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication

31. Renal failure requiring dialysis

32. Vulnerable subject

33. History of atriotomy or ventriotomy

34. Implanted endocardial left atrial appendage occlusion device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital (UAB)	Birmingham	Alabama	United States	35249
2	St. Bernards	Jonesboro	Arkansas	United States	72401
3	Arkansas Heart Hosptial	Little Rock	Arkansas	United States	72211
4	Scripps Health	La Jolla	California	United States	92037
5	Sequoia Hospital	Redwood City	California	United States	94062
6	South Denver Cardiology Associates	Littleton	Colorado	United States	80120
7	Florida Hospital	Orlando	Florida	United States	32803
8	Emory University Hosptial	Atlanta	Georgia	United States	30322
9	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
10	Johns Hopkins University Hospital	Baltimore	Maryland	United States	21287
11	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
12	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
13	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
14	Bryan Heart	Lincoln	Nebraska	United States	68506
15	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
16	New York University Hospital	New York	New York	United States	10016
17	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
18	Medical University of South Carolina	Charleston	South Carolina	United States	29425
19	Texas Cardiac Arrhythmia	Austin	Texas	United States	78705
20	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
21	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
22	Royal Melbourne Hospital - City Campus	Parkville	Victoria	Australia	3050

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 14, 2019
• Statistical Analysis Plan - May 27, 2020

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03650556
• Other Study ID Numbers: ABT-CIP-10239
• First Posted: Aug 28, 2018
• Last Update Posted: Apr 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Pre-assignment Detail	One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.

Arm/Group Title	Enrolled
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

Baseline Characteristics

Arm/Group Title	Ablation
Arm/Group Description	All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
Overall Participants	223
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.4 (10.1)
Sex: Female, Male (Count of Participants)
Female	69 30.9%
Male	154 69.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 1.3%
Not Hispanic or Latino	209 93.7%
Unknown or Not Reported	11 4.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	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%
Unknown or Not Reported	3 1.3%
Region of Enrollment (Count of Participants)
United States	209 93.7%
Australia	14 6.3%

Outcome Measures

1. Primary Outcome

Title	Rate of Subjects With a Device and/or Procedure-related SAE.
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

Outcome Measure Data

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
Arm/Group Description	A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Measure Participants	223
Count of Participants [Participants]	7 3.1%

2. Primary Outcome

Title	Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
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

Outcome Measure Data

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
Arm/Group Description	A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Measure Participants	190
Count of Participants [Participants]	114 51.1%

3. Secondary Outcome

Title	Acute Procedural Success
Description	Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
Time Frame	Immediate post procedure

Outcome Measure Data

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
Arm/Group Description	A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Measure Participants	223
Count of Participants [Participants]	219 98.2%

4. Secondary Outcome

Title	15-month Success Off of Antiarrhythmic Drugs
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

Outcome Measure Data

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
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
Measure Participants	190
Count of Participants [Participants]	89 39.9%

5. Secondary Outcome

Title	15 Month Single Procedure Success
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

Outcome Measure Data

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
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
Measure Participants	190
Count of Participants [Participants]	110 49.3%

Adverse Events

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
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 (%)	# Events
Total	2/224 (0.9%)
Serious Adverse Events
	Enrolled
	Affected / at Risk (%)	# Events
Total	59/224 (26.3%)
Cardiac disorders
Arrhythmia	9/224 (4%)	9
Coronary Artery Thrombosis/Occlusion	1/224 (0.4%)	1
Heart Failure/Pump Failure	3/224 (1.3%)	3
Valve Insufficiency	1/224 (0.4%)	1
Bradycardia	1/224 (0.4%)	1
Sick Sinus Symptom	1/224 (0.4%)	1
Sinus Bradycardia	1/224 (0.4%)	1
Chest Pain/Discomfort	8/224 (3.6%)	8
Cardiac Perforation or Tamponade	1/224 (0.4%)	1
Pericardial Effusion	3/224 (1.3%)	3
Gastrointestinal disorders
Acute Ischemic Colitis	1/224 (0.4%)	1
Bowel Obstruction	1/224 (0.4%)	1
Cholecystitis	1/224 (0.4%)	1
Colon Obstruction	1/224 (0.4%)	1
Lower GI Bleed	2/224 (0.9%)	2
Gastroparesis	1/224 (0.4%)	1
Colitis	1/224 (0.4%)	1
General disorders
Elective Procedure/Surgery	5/224 (2.2%)	5
Syncope/Dizziness	1/224 (0.4%)	1
Collapse	1/224 (0.4%)	1
Rectal and Vaginal Prolapse Repair	1/224 (0.4%)	1
Sudden Cardiac Death	1/224 (0.4%)	1
Trauma	1/224 (0.4%)	1
Jaw and Neck Pain	1/224 (0.4%)	1
Immune system disorders
Allergic Reaction	1/224 (0.4%)	1
Infections and infestations
Infection	4/224 (1.8%)	4
Pelvic Inflammatory Disease	1/224 (0.4%)	1
Urosepsis	1/224 (0.4%)	1
Pneumonia	1/224 (0.4%)	1
Musculoskeletal and connective tissue disorders
Fracture of Humerous	1/224 (0.4%)	1
Right Hip Fracture	1/224 (0.4%)	1
Nervous system disorders
Cerebrovascular Accident/Stroke	2/224 (0.9%)	3
Psychiatric disorders
Encephalopathy	1/224 (0.4%)	1
Renal and urinary disorders
Renal Decompensation/Acute Kidney Injury	1/224 (0.4%)	1
Urinary Retention	1/224 (0.4%)	1
Reproductive system and breast disorders
Penile Fracture	1/224 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema	1/224 (0.4%)	1
Respiratory Compromise/Decompensation	2/224 (0.9%)	2
Dyspnea	1/224 (0.4%)	1
Tracheobronchitis	1/224 (0.4%)	1
Vascular disorders
Bleeding/Anemia	5/224 (2.2%)	5
Hypertension	1/224 (0.4%)	1
Shock	1/224 (0.4%)	1
Volume Overload	3/224 (1.3%)	3
Hypotension	1/224 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Enrolled
	Affected / at Risk (%)	# Events
Total	29/224 (12.9%)
Blood and lymphatic system disorders
Thrombosis/Thrombus	1/224 (0.4%)	1
Elevated Troponin	1/224 (0.4%)	1
Trochanteric Bursitis	1/224 (0.4%)	1
Cardiac disorders
Arrhythmia	1/224 (0.4%)	1
Chest Pain/Discomfort	5/224 (2.2%)	5
Pericardial Effusion	2/224 (0.9%)	2
Pericarditis	1/224 (0.4%)	1
Congestive Heart Failure	1/224 (0.4%)	1
Gastrointestinal disorders
Esophageal Inflammation	1/224 (0.4%)	1
General disorders
Transient Ischemic Attack	1/224 (0.4%)	1
Cough	2/224 (0.9%)	2
Fluid Retention	1/224 (0.4%)	1
Headache	2/224 (0.9%)	2
Jaw Pain	1/224 (0.4%)	1
Hepatobiliary disorders
Hepatohepatomegaly With Elevated Liver Enzymes	1/224 (0.4%)	1
Infections and infestations
Infection	1/224 (0.4%)	1
Injury, poisoning and procedural complications
Air Embolism	1/224 (0.4%)	1
Musculoskeletal and connective tissue disorders
Shoulder Blade/ Arm Pit Pain	1/224 (0.4%)	1
Renal and urinary disorders
Urinary Retention	1/224 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	1/224 (0.4%)	1
Vascular disorders
Vascular Access Complication	2/224 (0.9%)	2
Vascular Bleeding/Local Hematoma/Ecchymosis	5/224 (2.2%)	5
Volume Overload	3/224 (1.3%)	3

Limitations/Caveats

[Not Specified]

More Information

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.