ArrhythmiasPhase 1NCT02110004
Picasso NAV High-Density Mapping Catheter for Signal Analysis of Complex Arrhythmias - First-In-Man
A Phase 1 study testing Ablation procedure and Picasso NAV Catheter in people with Arrhythmias, run by Biosense Webster, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Ablation procedure and Picasso NAV Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation.
- 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.
Who cannot join
- Subjects who meet any of the following exclusion criteria are not eligible for enrollment.
- 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.
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- 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.
About this study
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
- Being tested
- Ablation procedure, Picasso NAV Catheter
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation procedureProcedure or surgery
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.
Picasso NAV CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Ablation procedure | Other | Collect intra-cardiac signals Receives: Procedure: Ablation procedure; Device: Picasso NAV Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intra-procedure
Secondary outcomes (3)
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
Measured: Intra-procedure
Visualize the device
Ability to visualize the device
Measured by survey questions
Measured: Up to 3 months
Overall safety
Overall safety
- Primary Adverse Events
- Procedural complications
Measured by number and percentage of patients experiencing those adverse events
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom De Potter, Principal investigator, OLV HospitalPetr Neuzil, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110004
- Sponsor's protocol ID
- PIC-152
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2014
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Picasso NAV High-Density Mapping Catheter for Signal Analysis of Complex Arrhythmias - First-In-Man
- ClinicalTrials.gov ID
- NCT02110004
- Acronym / sponsor ID
- PIC-152
- Conditions
- Arrhythmias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation procedure | Other | Procedure: Ablation procedure, Device: Picasso NAV CatheterCollect intra-cardiac signals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation.
- 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
Key exclusion criteria (16 listed)
- Subjects who meet any of the following exclusion criteria are not eligible for enrollment.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation procedureThe 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. | Procedure or surgery | Ablation procedure |
| Picasso NAV Catheter | Device | Ablation procedure |
Primary outcome
Intra-procedural investigational device success
Time frame: Intra-procedure
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
3 secondary outcomes
Characterize the ideal workflow
Time frame: Intra-procedure
Visualize the device
Time frame: Up to 3 months
Overall safety
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom De Potter principal investigator
OLV Hospital
Petr Neuzil principal investigator
Na Homolce Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ablation procedure and Picasso NAV Catheter in people with Arrhythmias, run by Biosense Webster, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural investigational device success (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.