TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— TOCCASTAR  

Official title:

TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278953
• Other study ID #: VP-002 527
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Catheter ablation to treat paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	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.	12 months
Primary	Incidence of Device-related Early-onset Primary Serious Adverse Events	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.	12 months