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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01278953
First received: January 17, 2011
Last updated: August 6, 2014
Last verified: August 2014

January 17, 2011
August 6, 2014
January 2011
June 2013   (final data collection date for primary outcome measure)
  • Freedom from recurrence of symptomatic atrial fibrillation, atrial tachycardia or atrial flutter [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
  • Incidence of device-related early-onset primary serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
Same as current
Complete list of historical versions of study NCT01278953 on ClinicalTrials.gov Archive Site
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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
  • Experimental: TactiCath
    Ablation performed using the TactiCath contact force sensing catheter
    Intervention: Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
  • Active Comparator: Control
    Ablation performed using a catheter with no contact force sensing capability
    Intervention: Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2015
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01278953
VP-002 527
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
St. Jude Medical
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP