Trials / Completed
CompletedNCT04740801
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation: A Non-Randomized Prospective Study With Contact Force
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ablation procedure | Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2022-07-21
- Completion
- 2022-09-16
- First posted
- 2021-02-05
- Last updated
- 2023-05-11
Locations
5 sites across 3 countries: Germany, Italy, Spain
Source: ClinicalTrials.gov record NCT04740801. Inclusion in this directory is not an endorsement.