Status:
COMPLETED
TOCCATA - Touch+™ for Catheter Ablation
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Endosense
Conditions:
Atrial Fibrillation
Tachycardia, Supraventricular
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 fibrillati...
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 wit...
Eligibility Criteria
Inclusion
- Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia \[AVNRT\], accessory pathway Wolff Parkinson White \[WPW\] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation
Exclusion
- Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery
- Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart
- Known cerebrovascular disease, including a history of stroke or transient ischemic attack
- Left ventricular ejection fraction of \<35%
- Previous heart ablation procedure (surgical or catheter) to the target chamber
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01223469
Start Date
September 1 2008
End Date
February 1 2010
Last Update
January 30 2019
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