CompletedNot Applicable

TOCCATA - Touch+™ for Catheter Ablation

77 participantsStarted 2008-09

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Number of Subjects With Operative and Post-operative Serious Adverse Events

Timeframe: 3 months for AF arm; 7 days for the right SVT arm

Trial details

NCT IDNCT01223469

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-02

Results submitted2014-03-24

View on ClinicalTrials.gov More Atrial Fibrillation trials