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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04356040




Registration number
NCT04356040
Ethics application status
Date submitted
15/04/2020
Date registered
21/04/2020
Date last updated
3/05/2021

Titles & IDs
Public title
TactiFlex AF IDE Trial
Scientific title
Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Atrial Fibrillation
Secondary ID [1] 0 0
CRD_978
Secondary ID [2] 0 0
ABT-CIP-10303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal 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 - TactiFlex SE
Treatment: Devices - TactiFlex SE - HSP

Experimental: Main Study -

Experimental: HSP Sub-Study -


Treatment: Devices: TactiFlex SE
Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

Treatment: Devices: TactiFlex SE - HSP
Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.

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

Outcomes
Primary outcome [1] 0 0
Rate of Device or Procedure-related Serious Adverse Events - Outcome 1 is the rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below:
Atrio-esophageal fistula
Cardiac tamponade/perforation
Death
Heart block
Myocardial infarction
Pericarditis
Phrenic nerve injury resulting in diaphragmatic paralysis
Pulmonary edema
Pulmonary vein stenosis
Stroke/cerebrovascular accident
Thromboembolism
Transient ischemic attack
Vagal nerve injury/gastroparesis
Vascular access complications (including major bleeding events)
Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12 months.
Timepoint [1] 0 0
Through 12 months
Primary outcome [2] 0 0
Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence - Outcome 2 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).
AF/AFL/AT recurrence during the 90-day blanking period (=90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.
Timepoint [2] 0 0
Through 12 months
Secondary outcome [1] 0 0
Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence, without AADs - Outcome 3 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).
AF/AFL/AT recurrence during the 90-day blanking period (=90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III AAD will count as an effectiveness failure.
Timepoint [1] 0 0
Through 12 months
Secondary outcome [2] 0 0
Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence with only 1 ablation procedure - Outcome 4 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).
AF/AFL/AT recurrence during the 90-day blanking period (=90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Rate of freedom from symptomatic atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence - Outcome 5 for this clinical trial is freedom from documented symptomatic AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).
AF/AFL/AT recurrence during the 90-day blanking period (=90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.
Timepoint [3] 0 0
Through 12 months

Eligibility
Key inclusion criteria
A patient will be eligible for clinical trial participation if he/she meets the following
criteria:

1. Plans to undergo a catheter ablation procedure due to symptomatic PAF that is
refractory or intolerant to at least one Class I or III antiarrhythmic drug.

2. Physician's note indicating recurrent self-terminating AF

3. One electrocardiographically documented AF episode within 6-months prior to the
initial ablation procedure.

4. At least 18 years of age

5. Able and willing to comply with all trial requirements

6. Informed of the nature of the trial, agreed to its provisions and has provided written
informed consent as approved by the Institutional Review Board/Ethics Committee
(IRB/EC) of the respective clinical trial site.
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient will be excluded from enrollment in the clinical trial if he/she meets any of the
following criteria:

1. Persistent or long-standing persistent atrial fibrillation

2. Active systemic infection

3. Known presence of cardiac thrombus

4. Hypertrophic cardiomyopathy

5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol
intoxication, and other major surgical procedures in the 90-day period preceding
procedure

6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI), or valve or coronary bypass grafting surgery within 90 days of
procedure

7. Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography
or CT)

8. Left ventricular ejection fraction < 35% measured within 180 days of procedure
(echocardiography or CT)

9. New York Heart Association (NYHA) class III or IV

10. Previous left atrial surgical or catheter ablation procedure

11. Left atrial surgical procedure or incision with resulting scar (including LAA closure
device)

12. Previous tricuspid or mitral valve replacement or repair

13. Heart disease in which corrective surgery is anticipated within 180 days after the
procedure

14. Bleeding diathesis or suspected pro-coagulant state

15. Contraindication to long term anti-thromboembolic therapy

16. Presence of any condition that precludes appropriate vascular access

17. Renal failure requiring dialysis

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

19. Severe 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 severe chronic symptoms

20. Women who are pregnant or breastfeeding

21. Presence of other anatomic or comorbid condition that, in the investigator's opinion,
could limit the patient's ability to participate in the clinical trial or to comply
with follow up requirements, or impact the scientific soundness of the clinical trial
results

22. Patient is currently participating in another clinical trial or has participated in a
clinical trial within 30 days prior to screening that may interfere with this clinical
trial

23. Patient is unlikely to survive the protocol follow up period of 12-months after the
procedure

24. Body mass index > 40 kg/m2

25. Presence of other medical, social, or psychological conditions that, in the
investigator's opinion, could limit the subject's ability to participate in the
clinical investigation or to comply with follow-up requirements, or impact the
scientific soundness of the clinical investigation results.

26. Individuals without legal authority

27. Individuals unable to read or write

28. Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of
procedure,

29. Patients with prosthetic valves,

30. Patients with a myxoma,

31. Patients with an interatrial baffle or patch as the transseptal puncture could persist
and produce an iatrogenic atrial shunt

32. Patient unable to receive heparin or an acceptable alternative to achieve adequate
anticoagulation.

33. Stroke or TIA (transient ischemic attack) within the last 90 days

34. Stent, constriction, or stenosis in a pulmonary vein.

35. Rheumatic heart disease

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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)
NSW,QueenslVictor
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Wesley Private Hospital - Auchenflower
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
5067 - Adelaide
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
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Upr Aus
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Czechia
State/province [24] 0 0
Cbohmia
Country [25] 0 0
Germany
State/province [25] 0 0
N. Rhin
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Hong Ko
Country [28] 0 0
Italy
State/province [28] 0 0
Lombard
Country [29] 0 0
Netherlands
State/province [29] 0 0
S Holln
Country [30] 0 0
Taiwan
State/province [30] 0 0
Ntaiwan

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

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, non-randomized multi-center clinical investigation. Design includes a main study
and a separate substudy. Subjects in the main study are to be treated using the full range of
ablation power settings in the IFU. Subjects in the substudy are to be treated in the upper
end of the recommended ablation power settings (40-50 Watts).
Trial website
https://clinicaltrials.gov/show/NCT04356040
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristin Ruffner, PhD
Address 0 0
Clinical Program Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
George Galoussian
Address 0 0
Country 0 0
Phone 0 0
818 493 2156
Fax 0 0
Email 0 0
george.galoussian@abbott.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04356040