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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03354663




Registration number
NCT03354663
Ethics application status
Date submitted
17/11/2017
Date registered
28/11/2017
Date last updated
28/01/2020

Titles & IDs
Public title
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
Scientific 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
Secondary ID [1] 0 0
SJM-CIP-10216
Universal Trial Number (UTN)
Trial acronym
TactiSense
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TactiCath SE

Experimental: TactiCath SE - Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.


Treatment: Devices: TactiCath SE
Ablation to achieve pulmonary vein isolation.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
0 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ashford Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - City Campus - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Germany
State/province [13] 0 0
Saxony
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
Country [15] 0 0
Italy
State/province [15] 0 0
Lombardy
Country [16] 0 0
Italy
State/province [16] 0 0
Milan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03354663
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristin Ruffner, PhD MBA
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications