Trials / Completed
CompletedNCT01223469
TOCCATA - Touch+™ for Catheter Ablation
A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.
Detailed description
Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure. Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations. Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Contact force assisted irrigated RF ablation | radiofrequency ablation of atrial fibrillation or SVT |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2010-10-19
- Last updated
- 2019-01-30
- Results posted
- 2014-06-03
Source: ClinicalTrials.gov record NCT01223469. Inclusion in this directory is not an endorsement.