Clinical trial NCT05477147: Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
Official title: Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
AF
Artificial intelligence
Catheter Ablation
Ablation
Lead sponsor: Volta Medical
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 92
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.


Eligibility criteria: Inclusion Criteria:

1. Patients 21 years of age or older indicated for redo AF ablation
2. Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF
3. Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
4. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \> 4 weeks prior to ablation
5. Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
2. First AF ablation procedure indication was persistent AF lasting longer than 24 months
3. Long-standing persistent AF recurrence prior to study redo procedure
4. Previous AF ablation using VX1 software
5. Severe obesity (BMI \> 50)
6. Very dilated Left Atrium (LA) (e.g. LA diameter \> 55 mm and/or LA surface \> 40 cm2 determined by 2D echocardiography)
7. Patients with AF secondary to an obvious reversible cause
8. Inadequate anticoagulation as defined in the inclusion criteria
9. LA thrombus on Transesophageal Echocardiography (TEE)\* or CT Scan prior to procedure
10. Contraindications to anticoagulation (heparin, warfarin or NOAC)
11. Patients who are or may potentially be pregnant
12. Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
13. Myocardial infarction within the past 2 months (60 days)
14. Previous AV valve surgery
15. Patient diagnosed with hypertrophic cardiomyopathy
16. History of blood clotting or bleeding abnormalities
17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
18. Rheumatic Heart Disease
19. Cardiac Sarcoidosis
20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF \< 25%)
21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
22. Unstable angina within the past month
23. Acute illness or active systemic infection or sepsis
24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
25. Diagnosed atrial myxoma
26. Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
28. Enrollment in an investigational study evaluating another device, biologic, or drug
29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
30. Life expectancy or other disease processes likely to limit survival to less than 12 months
31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Primary outcomes:
measure: Freedom from AF
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Jacksonville
country: United States
facility: Ascension St. Vincent's Hospital
state: Florida
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research LLC
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Northwell Health System
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Aalst
country: Belgium
facility: OLV Aalst
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Toulouse
country: France
facility: Clinique Pasteur
city: München
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
References: