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Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

NCT03626649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-03

No results posted yet for this study

Summary

The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

Conditions

Interventions

DEVICE

DiamondTemp Cardiac Ablation System

The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: * DiamondTemp Ablation Catheter o Unidirectional and Bidirectional models * DiamondTemp Catheter-to RFG Cable * DiamondTemp GenConnect Cable * DiamondTemp FASTR Generator with Footswitch * DiamondTemp Irrigation Pump * DiamondTemp Irrigation Tubing Set

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Petr Neuzil, MD, PhD · Na Homolce

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-08-08
Completion
2019-08-08

Countries

  • Czechia
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT03626649 on ClinicalTrials.gov