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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278953
First Posted: January 19, 2011
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose

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.


Condition Intervention
Paroxysmal Atrial Fibrillation Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter [ Time Frame: 12 months ]
    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 ]
    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.


Enrollment: 295
Study Start Date: January 2011
Study Completion Date: September 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TactiCath
Ablation performed using the TactiCath contact force sensing catheter
Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
Active Comparator: Control
Ablation performed using a catheter with no contact force sensing capability
Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278953


Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278953     History of Changes
Other Study ID Numbers: VP-002 527
First Submitted: January 17, 2011
First Posted: January 19, 2011
Results First Submitted: January 7, 2016
Results First Posted: February 8, 2016
Last Update Posted: March 8, 2016
Last Verified: February 2016

Keywords provided by St. Jude Medical:
paroxysmal atrial fibrillation
atrial fibrillation
radiofrequency ablation
pulmonary vein isolation
ablation catheter
RF
contact force sensing
contact force
contact force assisted ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes