BradycardiaPOLARISNCT06453850
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
A study testing Use of FLEXIGO delivery catheter in people with Bradycardia and Cardiac Resynchronization Therapy, run by MicroPort CRM at 17 sites in 5 countries.
Trial summary
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
- What is being tested?
- Use of FLEXIGO delivery catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 14 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- 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
- Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker
- Patient planned for a catheter-guided implantation in the interventricular septum area
- Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
- Patient reviewed, signed and dated the Informed Consent Form (ICF)
- Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC
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- Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D
- Patient planned for a catheter-guided implantation in the interventricular septum area
- Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
- Patient reviewed, signed and dated the ICF
Who cannot join
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease
- Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
- Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
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- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Non-menopausal women
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease
- Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Non-menopausal women
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Spain5 sites
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitari i Politècnic La Fe
Valencia
France4 sites
Centre Hospitalier Annecy Genevois
Annecy
CHU Clermont-Ferrand
Clermont-Ferrand
Clinique du Millénaire
Montpellier
CHU Rouen Hôpital Charles Nicolle
Rouen
Italy4 sites
Arcispedale Sant'Anna - AO Univ.
Ferrara
Ospedale Maggiore della Carità - AO Univ.
Novara
Ospedale SS Annunziata
Taranto
Ospedale Ca' Foncello
Treviso
Portugal3 sites
ULS de Coimbra
Coimbra
ULS Lisboa Ocidental - Hospital de Santa Cruz
Lisbon
ULS Santa Maria
Lisbon
About this study
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Being tested
- Use of FLEXIGO delivery catheter
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of FLEXIGO delivery catheterDevice
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead
| Study group | Role | What they receive |
|---|---|---|
| FLEXIGO delivery catheter | Experimental | Not described Receives: Device: Use of FLEXIGO delivery catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting.
Measured: 72 hours after implantation
Secondary outcomes (5)
Implantation success rates
- Implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter.
- Left Bundle Branch Area Pacing (LBBAP) implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision.
- LBBAP implantation success rate (overall): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria.
Measured: During implantation
Implantation time
Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.
Measured: During implantation
Implantation usability
Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.
Measured: During implantation
Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
Proportion of SADE related to the FLEXIGO delivery catheter or the slitter.
Measured: 72 hours after implantation
Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
- LBBAP implantation success rate with FLEXIGO delivery catheter (documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision.
- LBBAP implantation success rate (overall, and documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria according to the operator's decision.
Measured: During implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start14 Feb 2025
- Primary completion6 Jun 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453850
- Sponsor's protocol ID
- DARI01 - POLARIS
- Acronym
- POLARIS
- Status last verified
- Sep 2026
- First submitted
- 29 May 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
- ClinicalTrials.gov ID
- NCT06453850
- Acronym / sponsor ID
- POLARIS / DARI01 - POLARIS
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 12 Jun 2024 (actual)
- 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 purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLEXIGO delivery catheter | Experimental | Device: Use of FLEXIGO delivery catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker
- Patient planned for a catheter-guided implantation in the interventricular septum area
- Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
- Patient reviewed, signed and dated the Informed Consent Form (ICF)
Key exclusion criteria (17 listed)
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease
- Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
- Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
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 |
|---|---|---|
| Use of FLEXIGO delivery catheterUse of FLEXIGO delivery catheter for implantation of ventricular pacing lead | Device | FLEXIGO delivery catheter |
Primary outcome
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Time frame: 72 hours after implantation
Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting.
5 secondary outcomes
Implantation success rates
Time frame: During implantation
Implantation time
Time frame: During implantation
Implantation usability
Time frame: During implantation
Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
Time frame: 72 hours after implantation
Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
Time frame: During implantation
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of FLEXIGO delivery catheter in people with Bradycardia and Cardiac Resynchronization Therapy, run by MicroPort CRM at 17 sites in 5 countries.
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 10 inclusion and 17 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, France, Italy, Portugal, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter (time frame: 72 hours after implantation). 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 23 Sep 2026.