TactiCath® Prospective Effectiveness Pilot Study

Paroxysmal Atrial Fibrillation Clinical Trial

— EFFICAS II  

Official title:

Efficacy Study on Atrial Fibrillation Percutaneous Catheter Ablation With Contact Force Support 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131337
• Other study ID #: EFFICAS II Version B
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Other:
• Electrophysiology study
after 3 months to check for pulmonary vein isolation (PVI) status

Locations

Country	Name	City	State
Czechia	IKEM	Prague
Czechia	Na Homolce	Prague
Germany	Asklepios St Georg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Endosense

Countries where clinical trial is conducted

Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pulmonary vein isolation (PVI) gaps per vein	Number of gaps in EFFICAS 2 is lower than in EFFICAS 1 and Contact force in EFFICAS 2 has reduced variability than in EFFICAS 1. Confounding parameters such as lesion continuity will be determined for the remaining gaps in EFFICAS 2.	3 months