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

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).

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Ablation procedure

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum am Urban
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe
• Italy
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino
  • Avellino
    • Mercogliano, Avellino, Italy, 83013
      • Casa di Cura Montevergine S.p.A.
• Spain
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Subjects who are eligible for an ablation procedure for paroxysmal AF according to international and local guidelines on catheter ablation of AF.
3. 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.
4. Subjects who are willing and capable of providing informed consent.
5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center.
6. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to local and national law.

Exclusion Criteria:

1. Any known contraindication to an AF ablation or anticoagulation
2. Continuous AF lasting longer than seven days from onset (no episodes within 365 days from enrollment)
3. History of previous LA ablation or surgical treatment for AF/AT/AFL
4. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
5. Subjects with life expectancy ≤ 6 months

6. Structural heart disease, heart conditions, or implanted devices as described below:

   1. Left ventricular ejection fraction < 35% based on the most recent imaging (≤ 180 days prior to enrollment)*
   2. LA diameter > 5.5 cm or LA volume >50 ml/m² indexed based on the most recent imaging (≤ 180 days prior to enrollment)*
   3. Heart failure with New York Heart Association (NYHA) Class III or IV
   4. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment
   5. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment
   6. Severe valvular disease or presence of a prosthetic - mechanical or biological - heart valve in the LA (not including valve repair and annular rings)
   7. Severe mitral valve regurgitation or stenosis
   8. Known or pre-existing severe pulmonary vein stenosis
   9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
   10. Presence of LA appendage occlusion device
   11. Presence of any pulmonary vein stents
   12. Unstable angina or ongoing myocardial ischemia
   13. Previous myocardial infarction within 90 days prior to enrollment
   14. Vena cava embolic protection filter devices and/or known femoral thrombus;
   15. Known left atrial thrombus, myxoma, or intracardiac mural thrombus
7. History of blood clotting or bleeding disease
8. Any prior history of documented cerebral infarct, TIA, or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment
9. Active systemic infection
10. 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)
11. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: PVI procedure; 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 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.

Device: Ablation procedure; Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-1 month

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Ignacio Garcia Bolao, MD, Clinica Universitaria de Navarra; Principal Investigator: Hüseyin Ince, MD, Vivantes Klinikum am Urban; Principal Investigator: Francesco Solimene, MD, Casa Di Cura 'Montevergine' S.P.A.; Principal Investigator: Armin Luik, MD, Staedtisches Klinikum Karlsruhe

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PM011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No