Identification for the Treatment of Complex Arrhythmias

Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565069
• Other study ID #: FIND-EU - CF163
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2015
• Last updated: April 3, 2018
• Start date: July 1, 2015
• Est. completion date: January 24, 2018

Study information

• Verified date: April 2018
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias

Intervention

Device:
• CartoFinder™ Device with CARTO® 3 System V5 Navigation
Ablation treatment

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis (OLV) Hospital	Aalst	Moorselbaan
Belgium	Algemeen Ziekenhuis (AZ) Sint Jan Brugge	Ruddershove	Brugge
Belgium	Universitair Ziekenhuis A ntwerpen (UZA)	Wilrijkstraat	Edegem
Czechia	Ceské Budejovice Hospital	Ceské Budejovice	Nemcové

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Belgium,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Evaluate Freedom from procedure-related primary adverse events	Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure	7 days
Secondary	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)
Secondary	Evaluate procedural results	Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation	Day 0 (procedure date)
Secondary	Evaluate procedural results	Proportion of subjects with AF organization after CF guided ablation	Day 0 (procedure date)
Secondary	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)
Secondary	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