TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (TactiSense)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TactiCath SE
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring paroxysmal atrial fibrillation, PAF, ablation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Arkansas Heart Hospital
- Scripps Health
- Sequoia Hospital
- South Denver Cardiology Associates, P.C.
- Washington Hospital Center
- Florida Hospital
- Emory University Hospital
- Central Baptist Hospital
- Mayo Clinic
- New York University Hospital
- Mount Sinai Hospital
- The Cleveland Clinic Foundation
- Medical University of South Carolina
- Texas Cardiac Arrhythmia
- Ashford Hospital
- Royal Adelaide Hospital
- Royal Melbourne Hospital - City Campus
- Herzzentrum Leipzig GmbH
- Herzzentrum Dresden GmbH Universitätsklinik
- Ospedale San Raffaele
- Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TactiCath SE
Arm Description
Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03354663
First Posted
November 17, 2017
Last Updated
October 6, 2023
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT03354663
Brief Title
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
Acronym
TactiSense
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
paroxysmal atrial fibrillation, PAF, ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TactiCath SE
Arm Type
Experimental
Arm Description
Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.
Intervention Type
Device
Intervention Name(s)
TactiCath SE
Intervention Description
Ablation to achieve pulmonary vein isolation.
Primary Outcome Measure Information:
Title
Rate of Serious Adverse Events
Description
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.
Time Frame
30 days
Title
Number of Participants With Procedural Success
Description
The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Time Frame
0 days
Other Pre-specified Outcome Measures:
Title
Average Power Delivered
Description
This outcome is the average power delivered for a case.
Time Frame
During Procedure
Title
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force
Description
Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
Time Frame
0 days
Title
Number of Participants Experiencing Serious Adverse Events Within 30 Days
Description
Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.
Time Frame
30 days
Title
Number of Participants Experiencing a Serious Adverse Event Within 1 Year
Description
Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
Time Frame
1 year
Title
One-year Freedom From AF
Description
One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.
Time Frame
1 year
Title
One-year Drug-free Success From AF
Description
One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.
Time Frame
1 year
Title
Changes in EQ-5D-5L Utility Scores
Description
Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.
Time Frame
1 year
Title
Changes in AFEQT Scores
Description
Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.
Time Frame
1 year
Title
Health Care Utilization
Description
Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.
Time Frame
1 year
Title
Force Time Integral (FTI)
Description
Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.
Time Frame
0 days
Title
Average Catheter Temperature
Description
This outcome is the average temperature (by lesion) for a case.
Time Frame
0 days
Title
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure
Description
This outcome is whether or not the recommended irrigation flow rate was used for a case.
Time Frame
0 days
Title
Contact Force During Procedure
Description
This outcome is the average contact force for a case.
Time Frame
0 days
Title
Total Procedure Time
Description
This outcome is the total procedure time for a case.
Time Frame
0 days
Title
Ablation Time - First to Last Ablation
Description
This outcome is the total ablation time for a case. This is the time from first to last ablation.
Time Frame
0 Days
Title
Fluoroscopy Time
Description
This outcome is the total fluoroscopy time for a case.
Time Frame
0 days
Title
Radiofrequency (RF) Application Time
Description
This outcome is the total RF application time for a case.
Time Frame
0 days
Title
Number of Participants Using AutoMark
Description
This outcome is the number of cases using AutoMark.
Time Frame
0 days
Title
Lesion Index (LSI)
Description
Mean lesion index (LSI) across lesions by subject
Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.
Time Frame
0 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Ruffner, PhD MBA
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
South Denver Cardiology Associates, P.C.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Ashford Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Royal Melbourne Hospital - City Campus
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Facility Name
Herzzentrum Dresden GmbH Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Ospedale San Raffaele
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20132
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
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