TactiCath® Prospective Effectiveness Pilot Study (EFFICAS II)

Abbott

Status

Completed

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Other: Electrophysiology study

Study type

Interventional

Funder types

Industry

Identifiers

NCT02131337

EFFICAS II Version B

Details and patient eligibility

About

EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.

Full description

EFFICAS II is a single-arm, prospective study, where the operator will have access to contact force information and use it actively to optimize the ablation result and adapting power if necessary. The endpoint will correlate contact force parameters initially applied in PV and 3 months PV isolation status, and compare results to those of EFFICAS I.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is at least 18 years of age but not over 75 years of age
Patient has at least one episode of sustained (>30s) paroxysmal atrial fibrillation documented by 12-lead ECG, holter monitor, transtelephonic event monitor, telemetry strip, or Pacemaker respectively implantable cardioverter defibrillator (ICD) within 12 months prior to enrolment
Patient has symptomatic paroxysmal atrial fibrillation (PAF) refractory or intolerant to at least one Class I-IV anti-arrhythmic drug
Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up scheme
Patient provides written informed consent prior to enrolment in the study

Exclusion criteria

Not adhering to inclusion criteria
Active systemic infection
Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
Reversible causes of Arrhythmia including thyroid disorders, acute alcohol intoxication, recent (less than 3 months) major surgical procedures
Patient has a left atrial diameter > 5.0 cm
Patient has persistent or long-standing persistent atrial fibrillation (AF)
Left ventricular ejection fraction < 35%
New York Heart Association (NYHA) class III or IV
Previous left atrial heart ablation procedure, either surgical or catheter ablation
Patient has an intracardiac mural thrombus or has had a ventriculotomy or atriotomy
Patient has moderate or severe structural heart disease as demonstrated by transthoracic or trans-esophageal echocardiogram of all four chambers of the heart (ventricular dysfunction or valve disease)
Tricuspid or mitral valve replacement or repair
If female of childbearing potential - pregnant or breastfeeding
Patient has a bleeding diathesis or suspected pro-coagulant state
Patient has contraindication to long-term antithromboembolic therapy (e. g. acetylsalicylic acid, heparin, warfarin)
Presence of condition that precludes appropriate vascular access
Heart disease in which corrective surgery is anticipated within 6 months
Renal failure requiring dialysis
Patient has a known sensitivity to contrast media (if needed during the procedure) that cannot adequately be controlled with pre-medication (or totally excluded)
Patient has other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
Patient is currently participating in another clinical trial
Patient is unlikely to survive over one year