At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
In Brief
A clinical study evaluating Catheter ablation to treat paroxysmal atrial fibrillation for Paroxysmal Atrial Fibrillation. Completed, enrolled 300 participants across 1 site.
Detailed Summary
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied. A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.
Study Details
Timeline
Interventions
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.