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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03650556




Registration number
NCT03650556
Ethics application status
Date submitted
1/08/2018
Date registered
28/08/2018
Date last updated
24/05/2019

Titles & IDs
Public title
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Scientific 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)
Secondary ID [1] 0 0
ABT-CIP-10239
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

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


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of device and/or procedure-related SAEs. - 1. Incidence of device and/or procedure-related SAEs with onset within 7-days of the ablation procedure.
Timepoint [1] 0 0
Within 7 days of initial and repeat procedure
Primary outcome [2] 0 0
Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence. - 2. Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence through 15-months.
Timepoint [2] 0 0
Through 15 months
Secondary outcome [1] 0 0
Acute Procedural Success - Acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Timepoint [1] 0 0
Immediate post procedure
Secondary outcome [2] 0 0
15-month Success off of Antiarrhythmic Drugs - Proportion 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.
Timepoint [2] 0 0
15 months
Secondary outcome [3] 0 0
15 Month Single Procedure Success - Proportion 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 will be deemed an effectiveness failure in this analysis.
Timepoint [3] 0 0
15 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - City Campus - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03650556
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laura Menck
Address 0 0
Country 0 0
Phone 0 0
651-756-2375
Fax 0 0
Email 0 0
laura.menck@abbott.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03650556