TactiCath® Prospective Effectiveness Pilot Study (EFFICAS II)

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

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

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Other: Electrophysiology study

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Na Homolce
  • Prague, Czechia
    • IKEM
• Germany
  • Hamburg, Germany
    • Asklepios St Georg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Contact force lesions	Other: Electrophysiology study; after 3 months to check for pulmonary vein isolation (PVI) status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Endosense

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (ESTIMATE): May 6, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EFFICAS II Version B