Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation
NCT02351999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-11-15
Summary
The study is a prospective, multi-center, non-randomized single arm interventional investigation with the TSP Crosser Transseptal Access System, a new complete solution for transseptal puncture and left atrial access and catheter navigation, for patients with atrial fibrillation ablation referred for radiofrequency catheter ablation.
Conditions
Interventions
- DEVICE
-
TSP Crosser Transseptal Access System
for transseptal puncture, left atrial access and catheter navigation.
Sponsors & Collaborators
-
Meditrial Europe Ltd.
collaborator INDUSTRY -
Transseptal Solutions Ltd.
lead INDUSTRY
Principal Investigators
-
Monica Tocchi, MD, PhD · Meditrial Europe Ltd.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-15
- Primary Completion
- 2018-09-30
- Completion
- 2019-04-30
Countries
- France
- Germany
Study Locations
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