Paroxysmal Atrial FibrillationTactiSenseNCT03354663
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
A study testing TactiCath SE in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 21 sites in 4 countries.
Trial summary
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). 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 SE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 11 Dec 2017to 30 Oct 2019
- 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
- Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug
- Physician's note indicating recurrent self-terminating AF
- One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure
- At least 18 years of age
- Able and willing to comply with all trial requirements
- Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Who cannot join
- Persistent or long-standing persistent atrial fibrillation (AF)
- Four or more cardioversions in the past 12 months
- Active systemic infection
- Known presence of cardiac thrombus
- Implanted with 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
Show all 26Show fewer
- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
- Left atrial diameter > 5.0 cm
- Left ventricular ejection fraction < 35%
- New York Heart Association (NYHA) class III or IV
- Previous left atrial surgical or catheter ablation procedure
- 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 procoagulant 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
- 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
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial 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 clinical trial
- Patient is unlikely to survive the protocol follow up period of 12 months
- Body mass index > 40 kg/m2
- Vulnerable subject
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States14 sites
Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Medical University of South Carolina
Charleston, South Carolina, 29425
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Scripps Health
La Jolla, California, 92037
Central Baptist Hospital
Lexington, Kentucky, 40503
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
South Denver Cardiology Associates, P.C.
Littleton, Colorado, 80120
New York University Hospital
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Florida Hospital
Orlando, Florida, 32803
Sequoia Hospital
Redwood City, California, 94062
Mayo Clinic
Rochester, Minnesota, 55905
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Australia3 sites
Ashford Hospital
Adelaide, 5000
Royal Adelaide Hospital
Adelaide
Royal Melbourne Hospital - City Campus
Melbourne, 3050
Germany2 sites
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Italy2 sites
Ospedale San Raffaele
Milan, Lombardy, 20132
Centro Cardiologico Monzino
Milan, 20138
About this study
Official title: Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.
Read the detailed description
This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- TactiCath SE
- Keywords
- paroxysmal atrial fibrillation, PAF, 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.
TactiCath SEDevice
Ablation to achieve pulmonary vein isolation.
| Study group | Role | What they receive |
|---|---|---|
| TactiCath SE | Experimental | Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. Receives: Device: TactiCath SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events
The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are:
- Atrial-esophageal fistula
- AV block
- Cardiac Perforation/ Tamponade
- Death
- Diaphragmatic paralysis
- Gastroparesis
- Hospitalization
- Myocardial Infarction
- Pericarditis
- Pneumothorax
- Pulmonary edema
- Pulmonary vein stenosis
- Stroke
- Thromboembolism
- Transient ischemic attack
- Vascular access complications
Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint.
Measured: 30 days
Number of Participants With Procedural Success
The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start11 Dec 2017
- Primary completion2 Aug 2018
- Study completion30 Oct 2019
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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD MBA, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354663
- Sponsor's protocol ID
- SJM-CIP-10216
- Acronym
- TactiSense
- Status last verified
- Oct 2023
- First submitted
- 17 Nov 2017
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03354663
- Acronym / sponsor ID
- TactiSense / SJM-CIP-10216
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, PAF, ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.
Detailed description
This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TactiCath SE | Experimental | Device: TactiCath SECatheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug
- Physician's note indicating recurrent self-terminating AF
- One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure
- At least 18 years of age
- Able and willing to comply with all trial requirements
Key exclusion criteria (26 listed)
- Persistent or long-standing persistent atrial fibrillation (AF)
- Four or more cardioversions in the past 12 months
- Active systemic infection
- Known presence of cardiac thrombus
- Implanted with implantable cardiac defibrillator (ICD)
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 SEAblation to achieve pulmonary vein isolation. | Device | TactiCath SE |
Primary outcome
Rate of Serious Adverse Events
Time frame: 30 days
The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint.
Number of Participants With Procedural Success
Time frame: 0 days
The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Paroxysmal Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
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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 MBA study director
Abbott
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TactiCath SE in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 21 sites in 4 countries.
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 26 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia, Germany, Italy. 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 20 Aug 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?
Rate of Serious Adverse Events (time frame: 30 days). 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 11 Oct 2023.