TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
This trial is active, not recruiting.
|Condition||paroxysmal atrial fibrillation|
|Treatment||catheter ablation for the treatment of paroxysmal atrial fibrillation|
|Sponsor||St. Jude Medical|
|Start date||January 2011|
|End date||June 2013|
|Trial size||400 participants|
|Trial identifier||NCT01278953, VP-002 527|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Freedom from recurrence of symptomatic atrial fibrillation, atrial tachycardia or atrial flutter
time frame: 12 months
Incidence of device-related early-onset primary serious adverse events
time frame: 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug - minimum one documented PAF episode >30 sec duration within prior 12 months - minimum three PAF episodes during prior 12 months - 18 years or older Exclusion Criteria: - persistent or long-standing persistent AF - four or more cardioversions in prior 12 months - MI, CABG or PCI within preceding 3 months - left atrial diameter > 5.0 cm - LVEF < 35% - NYHA class III or IV - previous left atrial ablation procedure - previous tricuspid or mitral valve repair surgery
|Official title||A Prospective, Randomized, Multicenter, Interventional Study to Evaluate the Safety and Effectiveness of the TactiCath Percutaneous Ablation Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Using Contact Force Assisted Radiofrequency Ablation|
|Principal investigator||Vivek Reddy, MD|
|Description||It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without. To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.|
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