Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Ablation performed using the TactiCath contact force sensing catheter
catheter ablation for the treatment of paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
(Active Comparator)
Ablation performed using a catheter with no contact force sensing capability
catheter ablation for the treatment of paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Primary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.