Paroxysmal Atrial FibrillationLOCALIZENCT03232645

Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation

A study testing Ablation procedure in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Paroxysmal Atrial Fibrillation
What is being tested?: Ablation procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 6 sitesin 4 countries
Study dates: 8 Jan 2018to 5 Aug 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD);
Eligible for an ablation procedure with the Rhythmia HDx mapping system (software version 2.0 or any future commercially available Software Version), IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter according to current international and local guidelines (and future revisions) and per physician discretion;
Subjects who are willing and capable of providing informed consent;
Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
Age 18 to 80

Who cannot join

• Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment:
New York Heart Association (NYHA) Class III or IV
Left ventricular ejection fraction (LVEF) <35%
Left atrial (LA) diameter >5.5 cm
Unstable angina or ongoing myocardial ischemia (OMI)
Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery

Show all 15Show fewer

Active systemic infection or sepsis;
Undergone any left atrial heart ablation procedure, either surgical or catheter ablation
Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
Subject has a Left Atrial Appendage Closure (LAAC) or Percutaneous Transcatheter Closure of a Patent Foramen Ovale (PFO)
Subject has persistent or long-standing persistent atrial fibrillation (AF) ( >1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year)
Life expectancy ≤ 6 months per physician judgment
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility;
The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

Germany2 sites

Universitäres Herzzentrum Hamburg
Hamburg
Stadtisches Klinikum Karlsruhe
Karlsruhe

Other trials in Germany

United Kingdom2 sites

Freeman Hospital
Newcastle
Southampton General Hospital
Southampton, SO16 6YD

Other trials in United Kingdom

France1 site

CHU de Bordeaux
Bordeaux

Other trials in France

Spain1 site

Clinica Universitaria de Navarra
Pamplona

Other trials in Spain

About this study

Official title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

Conditions: Paroxysmal Atrial Fibrillation
Being tested: Ablation procedure
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ablation procedureDevice
Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter

Study groups in NCT03232645
Study group	Role	What they receive
Rhythmia HDx and DirectSense technology	Other	Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Receives: Device: Ablation procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure.
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
Measured: Day 0 and 3 months

Secondary outcomes (5)

Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0).
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
Measured: Day 0
Number of Gaps at Day Zero
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.
Measured: Day 0
Baseline Local Impedance and Local Impedance Change at Day Zero
Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.
Measured: Day 0
Maximum Number of Gaps Per PV Segment at Day Zero
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.
Measured: Day 0
Local Impedance in Segments With Maximum Number of Gaps at Day Zero
Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 20185 Aug 2020

First posted28 Jul 2017
Study start8 Jan 2018
Primary completion23 Jun 2020
Study completion5 Aug 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 (1)Papers the sponsor has linked to this study.
Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232645
Sponsor's protocol ID: PM007
Acronym: LOCALIZE
Status last verified: Aug 2021
First submitted: 20 Jul 2017
Last updated: 5 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Publications

Garcia-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23.
PubMed 35589172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Paroxysmal Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
ClinicalTrials.gov ID: NCT03232645
Acronym / sponsor ID: LOCALIZE / PM007
Conditions: Paroxysmal Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 8 Jan 2018 (actual)
Primary completion: 23 Jun 2020 (actual)
Study completion: 5 Aug 2020 (actual)
First posted: 28 Jul 2017 (actual)
Results: Posted 9 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rhythmia HDx and DirectSense technology	Other	Device: Ablation procedureSubjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

• History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.

Key exclusion criteria (15 listed)

• Diagnosed with any of the following heart conditions within 90 days (3 months) prior to 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
Ablation procedureCathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter	Device	Rhythmia HDx and DirectSense technology

Primary outcome

Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
Time frame: Day 0 and 3 months
Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.

5 secondary outcomes

Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
Time frame: Day 0
Number of Gaps at Day Zero
Time frame: Day 0
Baseline Local Impedance and Local Impedance Change at Day Zero
Time frame: Day 0
Maximum Number of Gaps Per PV Segment at Day Zero
Time frame: Day 0
Local Impedance in Segments With Maximum Number of Gaps at Day Zero
Time frame: Day 0

Results and safety

Results posted to the registry on 9 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rhythmia HDx and DirectSense Technology	62	58

Primary outcome: Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment

Time frame: Day 0 and 3 months. Median (Inter-Quartile Range). Unit: ohm

Measure	Rhythmia HDx and DirectSense Technology n = 51
Local Impedance at Baseline in Pulmonary Veins segments where block was achieved	106.2 (96.6 to 117.4)
Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved	101.9 (92.8 to 113.9)
Local Impedance change in Pulmonary Veins segments where block was achieved	-19.6 (-27.5 to -13)
Local Impedance change in Pulmonary Veins segments where block was not achieved	-13.9 (-21.5 to -8.8)

Population analysed: 51 subjects were included in the analysis as 7 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment to end of follow-up: 4 Months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rhythmia HDx and DirectSense Technology	8 of 62 (12.9%)	4 of 62 (6.5%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35589172Garcia-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23.
Individual participant dataSharing planned: No. No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

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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.

Ignacio Garcia Bolao, MD principal investigator

Clinica Universitaria de Navarra

Bruno Reissmann, MD principal investigator

Universitäres Herzzentrum Hamburg

Armin Luik, MD principal investigator

Stadtisches Klinikum Karlsruhe

6 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ablation procedure in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 6 sites in 4 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 6 inclusion and 15 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, United Kingdom, France, Spain. 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 9 Aug 2021). 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?

Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment (time frame: Day 0 and 3 months). 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 NCT03232645, which also lists 1 linked publication.

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 Sep 2021.