Trials / Completed
CompletedNCT03903107
The Fluoroless-CSP Trial Using Electroanatomic Mapping
Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
Detailed description
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants. In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Conventional fluoroscopy guided Conduction System Pacing(CSP) | conventional standard approach Conduction System Pacing(CSP) using fluoroscopy |
| PROCEDURE | Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) | Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2021-04-01
- Completion
- 2024-09-30
- First posted
- 2019-04-04
- Last updated
- 2025-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03903107. Inclusion in this directory is not an endorsement.