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

NCT04740801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-11

No results posted yet for this study

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

Interventions

DEVICE

Ablation procedure

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ignacio Garcia Bolao, MD · Clinica Universitaria de Navarra

  • Hüseyin Ince, MD · Vivantes Klinikum am Urban

  • Francesco Solimene, MD · Casa Di Cura 'Montevergine' S.P.A.

  • Armin Luik, MD · Staedtisches Klinikum Karlsruhe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2022-07-21
Completion
2022-09-16

Countries

  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740801 on ClinicalTrials.gov