Paroxysmal Atrial FibrillationTactiCathPASNCT02310100
TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
A study testing TactiCath Quartz treatment in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 20 sites in United States.
Trial summary
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation. 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?
- TactiCath Quartz treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 Jan 2015to 17 Sep 2021
- 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
- Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug
- Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device
- Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
- Patient is 18 years of age or older
- Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
- Patient provides written informed consent prior to enrollment in the study
Who cannot join
- Persistent or long-standing persistent atrial fibrillation (AF)
- Patient has had 4 or more cardioversions in the past 12 months.
- Active systemic infection
- Presence of implantable cardiac defibrillator (ICD)
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
Show all 24Show fewer
- Left atrial diameter > 5.0 cm
- Left ventricular ejection fraction < 35%
- New York Heart Association (NYHA) class III or IV
- Previous left atrial ablation procedure, either surgical or catheter ablation
- Patient has had a left atrial surgical procedure or incision with resulting scar
- Previous tricuspid or mitral valve replacement or repair
- Heart disease in which corrective surgery is anticipated within 6 months
- Bleeding diathesis or suspected pro coagulant state
- Contraindication to long term antithromboembolic therapy
- Presence of any condition that precludes appropriate vascular access
- Renal failure requiring dialysis
- Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- Contraindication to computed tomography and magnetic resonance angiography
- Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Positive pregnancy test results for female patients of childbearing potential
- Patient has other anatomic or co morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
- Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study
- Patient is unlikely to survive the protocol follow up period of 12 months
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia
Austin, Texas, 78704
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
Glendale Memorial Hospital and Health Center
Glendale, California, 91204
The Methodist Hospital
Houston, Texas, 77030
Jackson Heart Clinic
Jackson, Mississippi, 39216
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Louisville
Louisville, Kentucky, 40202
Centennial Medical Center
Nashville, Tennessee, 37203
Mount Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Regional Cardiology Associates
Sacramento, California, 95819
Providence Hospital
Southfield, Michigan, 48075
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.
Read the detailed description
The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation.
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site.
After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- TactiCath Quartz treatment
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TactiCath Quartz treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| TactiCath Quartz | Experimental | TactiCath Quartz treatment Receives: Device: TactiCath Quartz treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)
Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.
Measured: 12 Months post ablation
Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event
The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study start21 Jan 2015
- Primary completionFeb 2017
- Study completion17 Sep 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310100
- Sponsor's protocol ID
- SJM-CIP-10030
- Acronym
- TactiCathPAS
- Status last verified
- Sep 2021
- First submitted
- 3 Dec 2014
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
- ClinicalTrials.gov ID
- NCT02310100
- Acronym / sponsor ID
- TactiCathPAS / SJM-CIP-10030
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 28 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.
Detailed description
The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation.
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site.
After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TactiCath Quartz | Experimental | Device: TactiCath Quartz treatmentTactiCath Quartz treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug
- Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device
- Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
- Patient is 18 years of age or older
- Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
Key exclusion criteria (24 listed)
- Persistent or long-standing persistent atrial fibrillation (AF)
- Patient has had 4 or more cardioversions in the past 12 months.
- Active systemic infection
- Presence of implantable cardiac defibrillator (ICD)
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
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 |
|---|---|---|
| TactiCath Quartz treatment | Device | TactiCath Quartz |
Primary outcome
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)
Time frame: 12 Months post ablation
Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.
Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event
Time frame: 7 days
The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristin Ruffner, PhD study director
Abbott
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TactiCath Quartz treatment in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 20 sites 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 6 inclusion and 24 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 28 Mar 2019). 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?
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) (time frame: 12 Months post ablation). 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?
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 12 Oct 2021.