Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (Tailored-AF)

  • STATUS
    Recruiting
  • End date
    Aug 24, 2023
  • participants needed
    374
  • sponsor
    Volta Medical
Updated on 24 May 2022
heparin
heart failure
warfarin
heart disease
infarct
fibrillation
noac
catheter ablation
persistent atrial fibrillation
pulmonary vein isolation
anticoagulation therapy
transesophageal echocardiography

Summary

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Details
Condition Atrial Fibrillation
Treatment PVI, Dispersion ablation + PVI, VX1
Clinical Study IdentifierNCT04702451
SponsorVolta Medical
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
Contraindications to anticoagulation (heparin, warfarin or NOAC)
Patients who are or may potentially be pregnant
Previous surgical or catheter ablation for AF
Any cardiac surgery within the past 2 months (60 days) (includes PCI)
Myocardial infarction within the past 2 months (60 days)
Previous AV valve surgery
History of blood clotting or bleeding abnormalities
Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
Rheumatic Heart Disease
Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
Unstable angina within the past month
Acute illness or active systemic infection or sepsis
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Diagnosed atrial myxoma
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)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Enrollment in an investigational study evaluating another device, biologic, or drug
Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
Life expectancy or other disease processes likely to limit survival to less than 12 months
Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Exclusion Criteria

Paroxysmal and short-standing AF < 3 months
Long-standing persistent AF > 5 years (≥ 1 year in the United States)
≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
Severe obesity (BMI > 40)
Very dilated Left Atrium (LA)(e.g. LA diameter > 60 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
Patients with AF secondary to an obvious reversible cause
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