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

NCT04740801 | Completed

• 1 other identifier: PM011
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 5

Brief 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 fibrillation (PAF).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

  0-3 months

Secondary Outcomes (1)

• Association between Local Impedance drop values and acute PV reconnections

  0-1 month

Study Arms (1)

PVI procedure

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 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

Interventions

Ablation procedure DEVICE

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

PVI procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Casa di Cura Montevergine S.p.A.

Mercogliano, Avellino, 83013, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: June 28, 2021
• Primary Completion: July 21, 2022
• Study Completion: September 16, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (2); IT (2)