Atrial FibrillationNCT05464537
Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
A study testing Unipolar Polarity Switch Left and Unipolar Polarity Switch Right in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
Trial summary
The technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Unipolar Polarity Switch Left and Unipolar Polarity Switch Right
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2023to 27 Nov 2024
- 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
- All Patients ≥ 18 years of age
- Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
Who cannot join
- Patients unable to give consent
- Who do not have De-novo AF.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
About this study
Official title: To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
The technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
Read the detailed description
One initial study reported that unipolar atrial EGM modification was a useful end point for RF energy delivery. They compared 2 groups of patients with paroxysmal AF undergoing PVI facilitated by an electroanatomic mapping system, merged preprocedural LA computed tomographic scan, and a circular mapping catheter.
They were the first to use intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI. The technique, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
As there is scant data is this area with lack of randomized human trials, planned on building and further validating evidence from Bortone et al in demonstrating that loss of unipolar negative component during PVI can serve a great adjuvant tool for achieving durability of PVI with overall lesser procedural time and no significant increase in adverse events.
- Conditions
- Atrial Fibrillation
- Being tested
- Unipolar Polarity Switch Left, Unipolar Polarity Switch Right
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar Polarity Switch LeftOther
10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP
Unipolar Polarity Switch RightOther
10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins
| Study group | Role | What they receive |
|---|---|---|
| Unipolar Polarity Switch Left and CAI-OPR-LAAP Right | Active comparator | Not described Receives: Other: Unipolar Polarity Switch Left |
| CAI-OPR-LAAP Left and Unipolar Polarity Switch Right | Active comparator | Not described Receives: Other: Unipolar Polarity Switch Right |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy rate of loss of unipolar negative component
Observe the efficacy rate of loss of unipolar negative component in isolation of the Pulmonary Veins. Loss of unipolar negative component will be assessed during the Radiofrequency ablation procedure. The durability of Pulmonary vein isolation will be assessed at 12 month follow up, if there is recurrence of Atrial fibrillation.
Measured: Procedure day and 12 month follow-up day
Number of patients with Esophageal Injury
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury
Measured: 1 year
Number of patients with TIA/CVA
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - transient ischemic attack/Cerebrovascular accident (TIA/CVA)
Measured: 1 year
Number of patients with Bleeding/Hematoma
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma
Measured: 1 year
Number of patients with Pericardial Effusion
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion
Measured: 1 year
Number of patients with need for open heart surgery
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - need for open heart surgery
Measured: 1 year
Number of patients with phrenic nerve injury
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - phrenic nerve injury
Measured: 1 year
Number of patients with pulmonary vein stenosis
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - pulmonary vein stenosis
Measured: 1 year
Esophageal Temp max (existing protocol)
Esophageal temp max (existing protocol)
Measured: 1 day
Esophageal "Time above threshold"
Esophageal "Time above threshold"
Measured: 1 day
Esophageal "Time to return to baseline"
Esophageal "Time to return to baseline"
Measured: 1 day
Images comparing PURE EP unipolar signals against Claris unipolar signals
Observe if the quality of PURE EP's unipolar signals are acutely and better suited for lesion assessment? This outcome compares mapping images with site of activation to the PURE EP electrogram and compare if they correspond to each other.
Measured: 1 day
Secondary outcomes (7)
Compare 1st pass isolation
Compare 1st pass isolation in the Unipolar polarity switch group to Carto's Ablation Index per Overland Park Regional's Left Atrial Ablation Protocol (CAI-OPR-LAAP)
Measured: 1 day
Total RF Time
Total RF Time in pulmonary veins with Unipolar polarity switch as endpoint vs. CAI-OPR-LAAP
Measured: 1 day
Discrimination with High Frequency Algorithm as a confirmation tool
In Left Superior Vein, Right Superior Vein, and Right Inferior Vein, validate Near Field and Far Field Discrimination with High Frequency Algorithm as a confirmation tool (Visitag #'s annotated into PURE EP)
Measured: 1 day
6-month freedom from AF
6-month freedom from AF
Measured: 6 months
Redo's within 1 year
Redo's within 1 year which vein randomized group reconnected
Measured: 1 year
Location of Catheter tip
Location of Catheter tip (LSPV, RSPV, RIPV, LIPV, LAA, Other) (carto image)
Measured: 1 day
Duration of HFA channel compared to Bipolar
Duration of HFA channel compared to Bipolar, Was there both a near and far field component?
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start28 Aug 2023
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Why it stopped: Company which provides funding is closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464537
- Sponsor's protocol ID
- KCHRRF-UNIPOLAR SWITCH-0013
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.
PubMed 26092576Pambrun T, Durand C, Constantin M, Masse A, Marra C, Meillet V, Haissaguerre M, Jais P, Bortone A. High-Power (40-50 W) Radiofrequency Ablation Guided by Unipolar Signal Modification for Pulmonary Vein Isolation: Experimental Findings and Clinical Results. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e007304. doi: 10.1161/CIRCEP.119.007304. Epub 2019 Jun 5.
PubMed 31164003Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.
PubMed 24097371
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT05464537
- Acronym / sponsor ID
- KCHRRF-UNIPOLAR SWITCH-0013
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company which provides funding is closed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 19 Jul 2022 (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 technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
Detailed description
One initial study reported that unipolar atrial EGM modification was a useful end point for RF energy delivery. They compared 2 groups of patients with paroxysmal AF undergoing PVI facilitated by an electroanatomic mapping system, merged preprocedural LA computed tomographic scan, and a circular mapping catheter.
They were the first to use intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI. The technique, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
As there is scant data is this area with lack of randomized human trials, planned on building and further validating evidence from Bortone et al in demonstrating that loss of unipolar negative component during PVI can serve a great adjuvant tool for achieving durability of PVI with overall lesser procedural time and no significant increase in adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unipolar Polarity Switch Left and CAI-OPR-LAAP Right | Active comparator | Other: Unipolar Polarity Switch Left |
| CAI-OPR-LAAP Left and Unipolar Polarity Switch Right | Active comparator | Other: Unipolar Polarity Switch Right |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All Patients ≥ 18 years of age
- Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
Key exclusion criteria (2 listed)
- Patients unable to give consent
- Who do not have De-novo AF.
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 |
|---|---|---|
| Unipolar Polarity Switch Left10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP | Other | Unipolar Polarity Switch Left and CAI-OPR-LAAP Right |
| Unipolar Polarity Switch Right10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins | Other | CAI-OPR-LAAP Left and Unipolar Polarity Switch Right |
Primary outcome
Efficacy rate of loss of unipolar negative component
Time frame: Procedure day and 12 month follow-up day
Observe the efficacy rate of loss of unipolar negative component in isolation of the Pulmonary Veins. Loss of unipolar negative component will be assessed during the Radiofrequency ablation procedure. The durability of Pulmonary vein isolation will be assessed at 12 month follow up, if there is recurrence of Atrial fibrillation.
Number of patients with Esophageal Injury
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury
Number of patients with TIA/CVA
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - transient ischemic attack/Cerebrovascular accident (TIA/CVA)
Number of patients with Bleeding/Hematoma
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma
Number of patients with Pericardial Effusion
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion
Number of patients with need for open heart surgery
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - need for open heart surgery
Number of patients with phrenic nerve injury
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - phrenic nerve injury
Number of patients with pulmonary vein stenosis
Time frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - pulmonary vein stenosis
Esophageal Temp max (existing protocol)
Time frame: 1 day
Esophageal temp max (existing protocol)
Esophageal "Time above threshold"
Time frame: 1 day
Esophageal "Time above threshold"
Esophageal "Time to return to baseline"
Time frame: 1 day
Esophageal "Time to return to baseline"
Images comparing PURE EP unipolar signals against Claris unipolar signals
Time frame: 1 day
Observe if the quality of PURE EP's unipolar signals are acutely and better suited for lesion assessment? This outcome compares mapping images with site of activation to the PURE EP electrogram and compare if they correspond to each other.
7 secondary outcomes
Compare 1st pass isolation
Time frame: 1 day
Total RF Time
Time frame: 1 day
Discrimination with High Frequency Algorithm as a confirmation tool
Time frame: 1 day
6-month freedom from AF
Time frame: 6 months
Redo's within 1 year
Time frame: 1 year
Location of Catheter tip
Time frame: 1 day
Duration of HFA channel compared to Bipolar
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Company which provides funding is closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 26092576Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.
- Background: PubMed 31164003Pambrun T, Durand C, Constantin M, Masse A, Marra C, Meillet V, Haissaguerre M, Jais P, Bortone A. High-Power (40-50 W) Radiofrequency Ablation Guided by Unipolar Signal Modification for Pulmonary Vein Isolation: Experimental Findings and Clinical Results. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e007304. doi: 10.1161/CIRCEP.119.007304. Epub 2019 Jun 5.
- Background: PubMed 24097371Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.
- Individual participant dataSharing planned: No
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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.
Dhanunjaya Lakkireddy principal investigator
Kansas City Heart Rhythm Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar Polarity Switch Left and Unipolar Polarity Switch Right in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Company which provides funding is closed). Results are not available in the source record.
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?
Efficacy rate of loss of unipolar negative component (time frame: Procedure day and 12 month follow-up day). The study lists 12 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 NCT05464537, which also lists 3 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 5 Mar 2025.