N/A N=300 Randomized Single-blind Treatment

TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Paroxysmal Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT01278953 ↗

Enrolled (actual)

300

Serious AEs

7.1%

Results posted

Feb 2016

Primary outcome: Primary: Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter — 99; 93 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Catheter ablation to treat paroxysmal atrial fibrillation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	99; 93	—
PRIMARY Incidence of Device-related Early-onset Primary Serious Adverse Events	3; 2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01278953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.