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Paroxysmal Atrial FibrillationLOCALIZE CFNCT04740801

Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)

A study testing Ablation procedure in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 5 sites in 3 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

The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial… Read more about this study

Who is it for?
Ages 18 years and older
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
60 participants
Where
5 sitesin 3 countries
Study dates
28 Jun 2021to 16 Sep 2022
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

  • History of recurrent, symptomatic, paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes at least one AF episode electrocardiographically documented and at least one additional symptomatic recurrence with or without electrocardiographic documentation, within 365 days prior to enrollment.
  • Subjects who are eligible for an ablation procedure for paroxysmal AF according to international and local guidelines on catheter ablation of AF.
  • Subjects refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, class I or III antiarrhythmic medication taken for the treatment of AF/AT (Atrial Tachycardia)/AFL (Atrial Flutter) or contraindicated to any class I or III antiarrhythmic medications, Beta Blocker or Calcium Channel Blocker.
  • 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.
  • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to local and national law.

Who cannot join

  • Any known contraindication to an AF ablation or anticoagulation
  • Continuous AF lasting longer than seven days from onset (no episodes within 365 days from enrollment)
  • History of previous LA ablation or surgical treatment for AF/AT/AFL
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Subjects with life expectancy ≤ 6 months
  • Structural heart disease, heart conditions, or implanted devices as described below:
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  • Left ventricular ejection fraction < 35% based on the most recent imaging (≤ 180 days prior to enrollment)*
  • LA diameter > 5.5 cm or LA volume >50 ml/m² indexed based on the most recent imaging (≤ 180 days prior to enrollment)*
  • Heart failure with New York Heart Association (NYHA) Class III or IV
  • Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment
  • Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment
  • Severe valvular disease or presence of a prosthetic - mechanical or biological - heart valve in the LA (not including valve repair and annular rings)
  • Severe mitral valve regurgitation or stenosis
  • Known or pre-existing severe pulmonary vein stenosis
  • Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
  • Presence of LA appendage occlusion device
  • Presence of any pulmonary vein stents
  • Unstable angina or ongoing myocardial ischemia
  • Previous myocardial infarction within 90 days prior to enrollment
  • Vena cava embolic protection filter devices and/or known femoral thrombus;
  • Known left atrial thrombus, myxoma, or intracardiac mural thrombus
  • History of blood clotting or bleeding disease
  • Any prior history of documented cerebral infarct, TIA, or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment
  • Active systemic infection
  • Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
  • Subjects who are currently enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without written approval from the sponsor

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Germany2 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

Other trials in Germany

Italy2 sites

  • Casa di Cura Montevergine S.p.A.

    Mercogliano, Avellino, 83013

  • Centro Cardiologico Monzino

    Milan, 20138

Other trials in Italy

Spain1 site

  • Clinica Universidad de Navarra

    Pamplona, 31008

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 With Contact Force

The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).

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

    Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter

Study groups in NCT04740801
Study groupRoleWhat they receive
PVI procedureOtherSubjects 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 4.0.1 or greater (commercially approved version) with DIRECTSENSE™ and Force Computation Software Module; the IntellaMap Orion mapping catheter and the IntellaNav StablePoint ablation catheter.
Receives: Device: Ablation procedure

What is being measured

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

  1. Association between Local Impedance drop values and PV reconnections

    Correlation between local impedance drop collected during the blinded index procedure and sites of late PV reconnection/durable block at 3-months.

    Measured: 0-3 months

Secondary outcomes (1)

  1. Association between Local Impedance drop values and acute PV reconnections

    Correlation between local impedance drop collected during the blinded index procedure and sites of acute gaps/block after a 20-minute wait period.

    Measured: 0-1 month

Timeline

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

  1. First posted5 Feb 2021
  2. Study start28 Jun 2021
  3. Primary completion21 Jul 2022
  4. Study completion16 Sep 2022

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04740801
Sponsor's protocol ID
PM011
Acronym
LOCALIZE CF
Status last verified
May 2023
First submitted
2 Feb 2021
Last updated
11 May 2023
Results posted
No
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

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 5 sites in 3 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 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Italy, 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?

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?

Association between Local Impedance drop values and PV reconnections (time frame: 0-3 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 NCT04740801.

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 11 May 2023.

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LOCALIZE CF Clinical Trial NCT04740801 | AzTrials