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

Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110004
• Other study ID #: PIC-152
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2014
• Last updated: June 9, 2015
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dutch (Belgium): Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)Czech: State Institute for Drug Control (SUKL)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation.

1. Age > 18 years or older.

2. Patients who have signed the Patient Informed Consent Form (ICF)

3. 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.)

4. 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

5. 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.

6. 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.

7. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not eligible for enrollment.

1. A complex arrhythmia secondary to a reversible cause.

2. Atrial arrhythmias: patients with a left atrial size >55 mm (echocardiography, parasternal long axis view).

3. Left Ventricular Ejection Fraction < 25%

4. NYHA Class III or IV

5. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

6. 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.

7. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor)

8. Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)

9. Any cardiac surgery within the past 60 days (2 months) (includes PCI)

10. Concurrent enrollment in a study evaluating another device or drug.

11. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause.

12. Presence of intra-cardiac thrombus or myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation.

13. Presence of a condition that precludes vascular access.

14. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation

15. Active illness or active systemic infection or sepsis.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias

Intervention

Procedure:
• Ablation 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.

Device:
• Picasso NAV Catheter

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst
Czech Republic	Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Belgium,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Characterize the ideal workflow	Characterize the ideal workflow (defined as catheter preparation, connectivity, and configuration) and the use of the Picasso NAV Catheter's ability to map areas of interest; Measured by survey questions	Intra-procedure	No
Secondary	Visualize the device	Ability to visualize the device; Measured by survey questions	Up to 3 months	Yes
Secondary	Overall safety	Overall safety; Primary Adverse Events; Procedural complications; Measured by number and percentage of patients experiencing those adverse events	Up to 7 days	Yes