Paroxysmal Atrial FibrillationTOCCASTARNCT01278953
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
A study testing Catheter ablation to treat paroxysmal atrial fibrillation in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Catheter ablation to treat paroxysmal atrial fibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Catheter ablation to treat paroxysmal atrial fibrillation
- Keywords
- paroxysmal atrial fibrillation, atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, ablation catheter, RF, contact force sensing, contact force, contact force assisted ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation to treat paroxysmal atrial fibrillationDevice
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| TactiCath | Experimental | Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability Receives: Device: Catheter ablation to treat paroxysmal atrial fibrillation |
| Control | Active comparator | Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability Receives: Device: Catheter ablation to treat paroxysmal atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278953
- Sponsor's protocol ID
- VP-002 527
- Acronym
- TOCCASTAR
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2011
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
PubMed 26260733
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01278953
- Acronym / sponsor ID
- TOCCASTAR / VP-002 527
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, ablation catheter, RF, contact force sensing, contact force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TactiCath | Experimental | Device: Catheter ablation to treat paroxysmal atrial fibrillationCatheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability |
| Control | Active comparator | Device: Catheter ablation to treat paroxysmal atrial fibrillationCatheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablation to treat paroxysmal atrial fibrillationA pulmonary vein isolation procedure will be performed using radiofrequency ablation. | Device | Control, TactiCath |
Primary outcome
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26260733Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation to treat paroxysmal atrial fibrillation in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.