Trials / Completed
CompletedNCT03626649
Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
Detailed description
* The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation. * In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2019-08-08
- Completion
- 2019-08-08
- First posted
- 2018-08-13
- Last updated
- 2021-02-03
Locations
4 sites across 2 countries: Czechia, France
Source: ClinicalTrials.gov record NCT03626649. Inclusion in this directory is not an endorsement.