Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Atrial Fibrillation Clinical Trial

— SPHERE Per-AF  

Official title:

Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120193
• Other study ID #: CP-00009
• Status: Completed
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: January 10, 2024

Study information

• Verified date: April 2024
• Source: Affera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.

2. Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).

3. Suitable candidate for catheter ablation.

4. Adults aged 18 - 80 years.

5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

6. Willing and able to provide informed consent.

Exclusion Criteria:

1. Continuous AF lasting for 12 months or longer.

2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.

3. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).

4. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).

5. Any carotid stenting or endarterectomy.

6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.

7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.

8. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.

9. Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).

10. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.

11. Documented left atrial thrombus on imaging.

12. History of blood clotting or bleeding abnormalities.

13. Any condition contraindicating chronic anticoagulation.

14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.

15. Body mass index >40 kg/m2.

16. Left atrial diameter >55 mm (anterioposterior).

17. Diagnosed atrial myxoma.

18. Left ventricular ejection fraction (EF) < 35%.

19. Uncontrolled heart failure or NYHA Class III or IV heart failure.

20. Rheumatic heart disease.

21. Hypertrophic cardiomyopathy.

22. Unstable angina.

23. Moderate to severe mitral valve stenosis.

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

25. Primary pulmonary hypertension.

26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.

27. Renal failure requiring dialysis.

28. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.

29. Acute illness, active systemic infection, or sepsis.

30. Contraindication to both computed tomography and magnetic resonance angiography.

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

32. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.

33. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.

34. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.

35. Known drug or alcohol dependency.

36. Life expectancy less than 12 months.

37. Vulnerable subject (such as a prisoner or handicapped or mentally disabled person).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Mapping and Ablation
Minimally invasive catheter mapping and ablation procedure

Locations

Country	Name	City	State
Czechia	Nemocnice Ceske Budejovice	Ceské Budejovice
Czechia	Institut Klinicke a Experimentani Mediciny	Praha 4
Czechia	Nemocnice Na Homolce	Praha 5
Israel	Shamir Medical Center	Zrifin
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Arrhythmia Institute at Grandview	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	The OhioHealth Research Institute	Columbus	Ohio
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Naples Heart Institute	Naples	Florida
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Northwell Health	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	AdventHealth Orlando	Orlando	Florida
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Pacific Heart Institute	Santa Monica	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	University of Pittsburgh Medical Center Pinnacle Health	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Affera, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with a primary adverse event	The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: Death; Myocardial infarction; Phrenic nerve paralysis; Transient ischemic attack (TIA); Stroke/cerebrovascular accident (CVA); Thromboembolism; Major vascular access complications / bleeding; Heart block; Gastroparesis; Severe pericarditis; Hospitalization due to cardiovascular or pulmonary AE; Within 30 days: • Cardiac tamponade / perforation; Within 90 days: • Atrio-esophageal fistula; Within 180 days: • Pulmonary vein stenosis	180 Days
Primary	Percent of subjects free from primary effectiveness failure	The primary effectiveness endpoint is freedom from documented recurrence of atrial tachyarrhythmias excluding the 90-day blanking period. The following are also considered primary effectiveness endpoint failures: Acute procedural failure; Non-study catheter failure; Repeat ablation/surgery failure; AAD failure; Cardioversion failure	12 months
Secondary	Energy application time	Total energy application time during the index ablation procedure	Day 0
Secondary	Treatment time	Time from start to end of energy delivery	Day 0
Secondary	Procedure time	Time from start to end of venous access	Day 0