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Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

NCT02275260 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-11-01

No results posted yet for this study

Summary

The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Cerebral Diffusion-Weighted Magnetic Resonance Imaging

Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)

DEVICE

Transesophageal Echocardiography

Patients undergo a Transesophageal Echocardiography prior to the ablation itself

OTHER

Paperbased neurocognitive testing

To assess the impact of PVI on the patient's neurocognitive status

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Dipen Shah, Prof. Dr. · Hôpitaux Universitaires de Genève, Switzerland

  • Boris Schmidt, PD Dr. · Cardioangiologisches Centrum Bethanien, Germany

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-02-08
Completion
2018-02-15

Countries

  • Czechia
  • Germany
  • Hungary
  • Netherlands
  • Switzerland

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 NCT02275260 on ClinicalTrials.gov