N/A N=77 Treatment

TOCCATA - Touch+™ for Catheter Ablation

Atrial Fibrillation · Tachycardia, Supraventricular

Bottom Line

View on ClinicalTrials.gov: NCT01223469 ↗

Enrolled (actual)

Serious AEs

6.5%

Results posted

Jun 2014

Primary outcome: Primary: Number of Subjects With Operative and Post-operative Serious Adverse Events — 4; 1 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Contact force assisted irrigated RF ablation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Operative and Post-operative Serious Adverse Events	4; 1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01223469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.