TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356040
• Other study ID #: ABT-CIP-10303
• Secondary ID: CRD_978
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Description:

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 paroxysmal atrial fibrillation

2. Physician's note indicating recurrent self-terminating atrial fibrillation

3. One electrocardiographically documented atrial fibrillation episode within 12-months prior to informed consent/enrollment. Documented evidence of the atrial fibrillation episode must either be continuous atrial fibrillation on a 12-lead ECG or include at least 30 seconds of atrial fibrillation from another ECG device.

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 of the respective clinical trial site.

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, acute coronary syndrome, percutaneous coronary intervention, 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 computerized tomography)

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

9. New York Heart Association class III or IV

10. Previous left atrial surgical or catheter ablation procedure

11. Left atrial surgical procedure or incision with resulting scar (including left atrial appendage 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 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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• TactiFlex SE
Radiofrequency ablation with the TactiFlex SE ablation catheter. 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.
• TactiFlex SE - High Standard Power
Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Wesley Private Hospital	Auchenflower	Queensl
Australia	The Prince Charles Hospital	Chermside	Queensl
Australia	Monash Medical Centre	Clayton	Victori
Australia	Westmead Hospital	Westmead	New South Wales
Austria	A. ö. Krankenhaus der Elisabethinen Linz	Linz	Upr Aus
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Czechia	IKEM Prague	Prague	Cbohmia
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen	N. Rhin
Germany	Herzzentrum Leipzig GmbH	Leipzig
Hong Kong	Prince of Wales Hospital	Hong Kong	Hong Ko
Italy	Ospedale San Raffaele	Milano	Lombard
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam	S Holln
Taiwan	Taipei Veterans General Hospital (VGH)	Taipei	Ntaiwan
United States	Piedmont Athens Regional Medical Center	Athens	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Affinity Cardiovascular Specialists, LLC	Birmingham	Alabama
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mills-Peninsula Medical Center	Burlingame	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Kootenai Heart Clinics	Coeur d'Alene	Idaho
United States	Ohio State University	Columbus	Ohio
United States	Memorial Hermann Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	Scripps Health	La Jolla	California
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Hospital	New York	New York
United States	New York-Presbyterian/Columbia University Medical Center	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	Providence Hospital	Southfield	Michigan
United States	Franciscan Heart & Vascular Associates	Tacoma	Washington
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  Germany,  Hong Kong,  Italy,  Netherlands,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Device or Procedure-related Serious Adverse Events	Tthe 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 fistula1; Cardiac tamponade/perforation1; Death; Heart block; Myocardial infarction; Pericarditis; Phrenic nerve injury resulting in diaphragmatic paralysis; Pulmonary edema; Pulmonary vein stenosis1; 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.	Through 12 months
Primary	KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence	Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. 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 anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose.	Through 12 months
Secondary	KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence	Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. 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 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 anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose.	Through 12 months
Secondary	KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure	Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. 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 anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose.	12 months
Secondary	KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs	Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). 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 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 anti-arrhythmic drugs will count as an effectiveness failure.	Through 12 months