An interventional study of Catheter ablation to treat paroxysmal atrial fibrillation in Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
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.
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 300 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability
Device: Catheter ablation to treat paroxysmal atrial fibrillation
Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability
Device: Catheter ablation to treat paroxysmal atrial fibrillation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
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
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
| Milestone | TactiCath | Control |
|---|---|---|
| Started | 155 | 145 |
| Completed | 146 | 134 |
| Not completed | 9 | 11 |
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.
| participants | TactiCath | Control |
|---|---|---|
| Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 99 | 93 |
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.
| participants | TactiCath | Control |
|---|---|---|
| Incidence of Device-related Early-onset Primary Serious Adverse Events | 3 | 2 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TactiCath | — | 10/152 (6.6%) | 70/152 (46.1%) |
| Control | — | 11/143 (7.7%) | 56/143 (39.2%) |
| Event | TactiCath | Control |
|---|---|---|
| HospitalizationGeneral disorders | 4/152 | 5/143 |
| Vascular Access ComplicationVascular disorders | 3/152 | 3/143 |
| Pulmonary edemaRespiratory, thoracic and mediastinal disorders | 2/152 | 2/143 |
| Atrial PerforationCardiac disorders | 0/152 | 1/143 |
| Cardiac perforationCardiac disorders | 1/152 | 0/143 |
| Event | TactiCath | Control |
|---|---|---|
| Cardiac disordersCardiac disorders | 38/152 | 36/143 |
| Vascular disordersVascular disorders | 17/152 | 9/143 |
| Repiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 11/152 | 3/143 |
| General disordersGeneral disorders | 6/152 | 7/143 |
| Nervous systems disordersNervous system disorders | 7/152 | 2/143 |
| InvestigationsInvestigations | 6/152 | 6/143 |
| Gastrointestinal disordersGastrointestinal disorders | 4/152 | 4/143 |
| Renal and urinary disordersRenal and urinary disorders | 4/152 | 4/143 |
| Infection and infestationsInfections and infestations | 4/152 | 2/143 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 2/152 | 3/143 |
| Age, Continuous(years) | TactiCath | Control | Total |
|---|---|---|---|
| Mean | 59.6 ± 9.32 | 61 ± 10.84 | 60.3 ± 10.09 |
| Sex: Female, Male(Participants) | TactiCath | Control | Total |
|---|---|---|---|
| Female | 55 | 54 | 109 |
| Male | 100 | 91 | 191 |
| Race (NIH/OMB)(Participants) | TactiCath | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 148 | 141 | 289 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | TactiCath | Control | Total |
|---|---|---|---|
| United States | 96 | 87 | 183 |
| Europe | 59 | 58 | 117 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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