TactiCath® Prospective Effectiveness Pilot Study

NCT02131337 | Completed

• 1 other identifier: EFFICAS II Version B
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Contact force lesions

OTHER

Other: Electrophysiology study

Interventions

Electrophysiology study OTHER

after 3 months to check for pulmonary vein isolation (PVI) status

Contact force lesions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Endosense: collaborator

Study Sites (3)

IKEM

Prague, Czechia

Location

Na Homolce

Prague, Czechia

Location

Asklepios St Georg

Hamburg, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 6, 2014
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

DE (1); CZ (2)