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

STATUS

Recruiting
End date

Aug 24, 2023
participants needed

374
sponsor

Volta Medical

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Updated on 24 May 2022

See if I qualify

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 Identifier	NCT04702451
Sponsor	Volta Medical
Last Modified on	24 May 2022

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