Trials / Completed
CompletedNCT00469638
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.
Detailed description
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation. Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Left atrial catheter ablation guided by introducer using Agilis sheeth | Left atrial catheter ablation guided by introducer using Agilis sheeth |
| PROCEDURE | Left atrial catheter ablation guided by introducer using Non-steerable sheeth | Left atrial catheter ablation guided by introducer using Non-steerable sheeth |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2007-05-04
- Last updated
- 2019-02-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00469638. Inclusion in this directory is not an endorsement.