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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110004
Other study ID # PIC-152
Secondary ID
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


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
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