Identification for the Treatment of Complex Arrhythmias

Identification for the Treatment of Complex Arrhythmias (CartoFinder™ Algorithm Trial: "CF163 EU")

The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.

Study Overview

• Status: Completed
• Conditions: Arrhythmias
• Intervention / Treatment: Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brugge
    • Ruddershove, Brugge, Belgium, 10 - 8000
      • Algemeen Ziekenhuis (AZ) Sint Jan Brugge
  • Edegem
    • Wilrijkstraat, Edegem, Belgium, 10 - 2650
      • Universitair Ziekenhuis A ntwerpen (UZA)
  • Moorselbaan
    • Aalst, Moorselbaan, Belgium, 164 - 9300
      • Onze-Lieve-Vrouwziekenhuis (OLV) Hospital
• Czechia
  • Němcové
    • České Budějovice, Němcové, Czechia, 585/54 - 370 01
      • Ceske Budejovice Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Signed the Patient Informed Consent Form (ICF)

3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of

   • Persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).
   • Drug-resistant Atrial Fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
   • Persistent AF despite prior conventional ablation.
4. Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
5. In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

1. Paroxysmal Atrial Fibrillation
2. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
3. Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) > 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure.
4. A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease.
5. Left atrial size >55 mm (echocardiography, parasternal long axis view).
6. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
7. Structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.
8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor), significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.
9. Enrollment in an experimental study evaluating another device or drug under investigation.
10. Prosthetic valve
11. Presence of intramural thrombus, tumor or other abnormality / condition that precludes vascular access, catheter introduction or manipulation.
12. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.
13. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Use of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias	Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation; Ablation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify rate of slowing for the overall mean atrial fibrillation rate	Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm	Day 0 (procedure date)
Evaluate Freedom from procedure-related primary adverse events	Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate procedural results	Proportion of subjects with focal impulses / Repetitive Activation Pattern (RAP)s and number of areas and locations of focal impulses / RAPs	Day 0 (procedure date)
Evaluate procedural results	Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation	Day 0 (procedure date)
Evaluate procedural results	Proportion of subjects with AF organization after CF guided ablation	Day 0 (procedure date)
Evaluate procedural results	Proportion of subjects with acute procedural success, i.e. subjects with spontaneous return to NSR or AF organization after CF guided ablation	Day 0 (procedure date)
Evaluate freedom from documented recurrence of atrial fibrillation	Evaluate freedom from documented recurrence of atrial fibrillation at 6 and 12 months post-procedure	6 and 12 months

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 24, 2017
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: FIND-EU - CF163