Atrial FibrillationNCT04210622
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A study testing Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System in people with Atrial Fibrillation and Atrial Flutter, run by Medtronic Cardiac Ablation Solutions at 1 site in Lithuania.
Trial summary
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2018to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 75 years.
- Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:
- Atrial Flutter defined as
- o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- OR
- Atrial Fibrillation defined as
Show all 10Show fewer
- History of symptomatic paroxysmal and/or persistent atrial fibrillation within the past year documented by EKG AND
- Failure of at least one class I-IV drug as evidenced by recurrent symptomatic AF, or intolerable to AAD.
- Subject is able and willing to give informed consent.
- Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.
Who cannot join
- Documented left atrial thrombus or another abnormality which precludes catheter introduction.
- Documented ejection fraction (EF) < 40%.
- Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
- Congenital heart disease where the underlying abnormality increases the risk of the ablation.
Show all 26Show fewer
- Pulmonary hypertension (mean pulmonary artery pressure [mPAP] > 50 mmHg)
- Enrollment in any other ongoing study protocol that would interfere with this study.
- Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) < 29ml/min.
- Active gastrointestinal (GI) bleeding.
- Active infection or sepsis.
- Short life expectancy (< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
- Significant anemia (defined as hemoglobin < 8.0 gr/dL).
- Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within last 30 days.
- Severe bleeding, clotting or thrombotic disorder.
- Uncontrolled diabetes.
- Women who are pregnant or are not willing to use contraception for the duration of the study.
- Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] <1)
- Prior stroke or TIA within the last 6 months.
- Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.
- Additional exclusion criteria for AF patients only
- Left atrial diameter of > 55 mm (parasternal view).
- Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
- Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.
- Prior ablation or surgery for atrial fibrillation.
- NYHA Class III or IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Initial Assessment of the Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation SystemDevice
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
| Study group | Role | What they receive |
|---|---|---|
| Subjects who are treated with the Sphere-9™ Catheter | Experimental | Not described Receives: Device: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Primary Safety Event
The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment); valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death.
Measured: 90 days
Number of Positive (Affirmative) Product Performance Responses
The primary product performance outcome is determined during the procedure and is defined as the following:
- Catheter handling sufficient to reach reasonable intended targets, as determined by the physician:
- catheter delivery to the desired cardiac chambers
- manipulation of catheter
- completion of mapping procedure
- safe removal of catheter from the subject
- 3D electro-anatomical map creation and utility sufficient to aid diagnosis
- Generation of acceptable acute therapeutic RF lesions
Measured: Index ablation procedure
Secondary outcomes (1)
Number of Subjects Free From Documented Recurrence
The secondary product performance outcome is freedom from documented recurrence of the treated arrhythmia through the Day 365 post-treatment follow-up visit. In AF subjects, this includes freedom from documented AF, atrial tachycardia (AT), or AFL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 May 2018
- Primary completion4 Jul 2019
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210622
- Sponsor's protocol ID
- CP-00001A
- Status last verified
- May 2025
- First submitted
- 22 Dec 2019
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable Lattice Electrode Ablation Catheter: A Novel Radiofrequency Platform Allowing High Current at Low Density for Rapid, Titratable, and Durable Lesions. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007090. doi: 10.1161/CIRCEP.118.007090.
PubMed 30943762Kitamura T, Hocini M, Bourier F, Martin R, Takigawa M, Frontera A, Thompson N, Cheniti G, Vlachos K, Martin CA, Lam A, Duchateau J, Pambrun T, Denis A, Sacher F, Derval N, Cochet H, Haissaguerre M, Jais P. Larger and deeper ventricular lesions using a novel expandable spherical monopolar irrigated radiofrequency ablation catheter. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1644-1651. doi: 10.1111/jce.14089. Epub 2019 Aug 1.
PubMed 31347223
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Assessment of the Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial Arrhythmias
- ClinicalTrials.gov ID
- NCT04210622
- Acronym / sponsor ID
- CP-00001A
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who are treated with the Sphere-9™ Catheter | Experimental | Device: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 and < 75 years.
- Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:
- o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- OR
- Subject is able and willing to give informed consent.
Key exclusion criteria (26 listed)
- Documented left atrial thrombus or another abnormality which precludes catheter introduction.
- Documented ejection fraction (EF) < 40%.
- Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
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 |
|---|---|---|
| Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation SystemCatheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System | Device | Subjects who are treated with the Sphere-9™ Catheter |
Primary outcome
Number of Subjects With a Primary Safety Event
Time frame: 90 days
The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment); valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death.
Number of Positive (Affirmative) Product Performance Responses
Time frame: Index ablation procedure
The primary product performance outcome is determined during the procedure and is defined as the following: * Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired cardiac chambers * manipulation of catheter * completion of mapping procedure * safe removal of catheter from the subject * 3D electro-anatomical map creation and utility sufficient to aid diagnosis * Generation of acceptable acute therapeutic RF lesions
1 secondary outcome
Number of Subjects Free From Documented Recurrence
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30943762Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable Lattice Electrode Ablation Catheter: A Novel Radiofrequency Platform Allowing High Current at Low Density for Rapid, Titratable, and Durable Lesions. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007090. doi: 10.1161/CIRCEP.118.007090.
- Background: PubMed 31347223Kitamura T, Hocini M, Bourier F, Martin R, Takigawa M, Frontera A, Thompson N, Cheniti G, Vlachos K, Martin CA, Lam A, Duchateau J, Pambrun T, Denis A, Sacher F, Derval N, Cochet H, Haissaguerre M, Jais P. Larger and deeper ventricular lesions using a novel expandable spherical monopolar irrigated radiofrequency ablation catheter. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1644-1651. doi: 10.1111/jce.14089. Epub 2019 Aug 1.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System in people with Atrial Fibrillation and Atrial Flutter, run by Medtronic Cardiac Ablation Solutions at 1 site in Lithuania.
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 26 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. 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?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With a Primary Safety Event (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210622, which also lists 2 linked publications.
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 16 May 2025.