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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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.


Estimated Enrollment: 400
Study Start Date: January 2011
Estimated Study Completion Date: August 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278953

Locations
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Renata Beloumari    212-241-7272    renata.beloumari@mountsinai.org   
Principal Investigator: Srinivas Dukkipati, MD         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278953     History of Changes
Other Study ID Numbers: VP-002 527
Study First Received: January 17, 2011
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014