Picasso NAV High-Density Mapping Catheter for Signal Analysis of Complex Arrhythmias - First-In-Man

NCT02110004 | Completed Phase 1 DMC

• 1 other identifier: PIC-152
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.

Conditions

Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Intra-procedural investigational device success

  Intra-procedural investigational device success * Ability to deploy the Picasso NAV Catheter within the atria and/or ventricles * The collection of intra-cardiac signals in the atria and/or ventricles Measured by number and percentage of physicians able to deploy and collect intra-cardiac signals as outlined in the protocol

  Intra-procedure

Secondary Outcomes (3)

• Characterize the ideal workflow

  Intra-procedure

• Visualize the device

  Up to 3 months

• Overall safety

  Up to 7 days

Study Arms (1)

Ablation procedure

OTHER

Collect intra-cardiac signals

Procedure: Ablation procedure; Device: Picasso NAV Catheter

Interventions

Ablation procedure PROCEDURE

The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intra-cardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.

Ablation procedure

Picasso NAV Catheter DEVICE

Ablation procedure

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years or older.
• Patients who have signed the Patient Informed Consent Form (ICF)
• Patients who are scheduled to undergo a clinically-indicated catheter ablation procedure for the management of a complex arrhythmia. (Patients having undergone a previous ablation procedure may be included.)
• Subjects who have failed at least one antiarrhythmic drug (AAD) (including AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic complex arrhythmia, or intolerable to the AAD
• Complex arrhythmias (including atrial fibrillation, atypical flutter, ventricular tachycardia) defined as patients who have been diagnosed with a complex arrhythmia anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
• At least one episode of the complex arrhythmia must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

You may not qualify if:

• A complex arrhythmia secondary to a reversible cause.
• Atrial arrhythmias: patients with a left atrial size \>55 mm (echocardiography, parasternal long axis view).
• Left Ventricular Ejection Fraction \< 25%
• NYHA Class III or IV
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• Atrial arrhythmias: patients with 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.
• History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor)
• Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Any cardiac surgery within the past 60 days (2 months) (includes PCI)
• Concurrent enrollment in a study evaluating another device or drug.
• A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause.
• Presence of intra-cardiac thrombus or myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation.
• Presence of a condition that precludes vascular access.
• Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
• Active illness or active systemic infection or sepsis.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom De Potter

  OLV Hospital

  PRINCIPAL INVESTIGATOR

• Petr Neuzil

  Na Homolce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 3, 2025

Record last verified: 2025-01