Paroxysmal Atrial Fibrillation
Conditions
Keywords
paroxysmal atrial fibrillation, atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, ablation catheter, RF, contact force sensing, contact force, contact force assisted ablation
Brief 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.
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.
Interventions
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
300 subjects consented and were randomized, 5 subjects did not have the study device introduced. Thus 295 subjects contributed to study endpoints.
Participants by arm
| Arm | Count |
|---|---|
| TactiCath Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation. | 155 |
| Control Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation. | 145 |
| Total | 300 |
Baseline characteristics
| Characteristic | TactiCath | Control | Total |
|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 9.32 | 61 years STANDARD_DEVIATION 10.84 | 60.3 years STANDARD_DEVIATION 10.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 148 Participants | 141 Participants | 289 Participants |
| Region of Enrollment Europe | 59 participants | 58 participants | 117 participants |
| Region of Enrollment United States | 96 participants | 87 participants | 183 participants |
| Sex: Female, Male Female | 55 Participants | 54 Participants | 109 Participants |
| Sex: Female, Male Male | 100 Participants | 91 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 70 / 152 | 56 / 143 |
| serious Total, serious adverse events | 10 / 152 | 11 / 143 |
Outcome results
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.
Time frame: 12 months
Population: Primary effectiveness was calculated using the Per Protocol (PP) population (n=280). 10 subjects who had PVI attempted were excluded from the PP population.due to insufficient data. A medical panel (DSMB) blinded to treatment, adjudicated the exclusion of subjects from the analysis (n=3 from TactiCath; n=7 from Control)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TactiCath | Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 99 participants |
| Control | Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 93 participants |
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.
Time frame: 12 months
Population: The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. (n=3 excluded from TactiCath; n=2 excluded from the Control group)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TactiCath | Incidence of Device-related Early-onset Primary Serious Adverse Events | 3 participants |
| Control | Incidence of Device-related Early-onset Primary Serious Adverse Events | 2 participants |