Trial Outcomes & Findings for Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation. (NCT NCT03459196)
NCT ID: NCT03459196
Last Updated: 2025-06-29
Results Overview
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
COMPLETED
NA
54 participants
Day 1
2025-06-29
Participant Flow
A total of 54 subjects were enrolled in the study at 7 sites in Europe. The first subject was enrolled on April 17th, 2018 and the last subject was enrolled on June 20th, 2018.
Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects were screened using pre-procedure imaging for the presence of LA thrombus, which was intended to decrease the potential for thromboembolic complications.
Participant milestones
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
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Overall Study
STARTED
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54
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
|
Overall Study
Subject didn't receive study catheter
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
n=54 Participants
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 12.01 • n=54 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=54 Participants
|
|
Region of Enrollment
European Union
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54 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Outcome measures
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
n=52 Participants
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
|
Number of Subjects Achieved Acute Procedural Success
|
52 Participants
|
PRIMARY outcome
Timeframe: 7 days post-procedurePopulation: Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.
Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
Outcome measures
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
n=52 Participants
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
|
Incidence of Acute Safety
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2 Participants
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Adverse Events
THERMOCOOL SMARTTOUCH SF-5D Catheter
Serious adverse events
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
n=52 participants at risk
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Cardiac disorders
Atrial flutter
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
Other adverse events
| Measure |
THERMOCOOL SMARTTOUCH SF-5D Catheter
n=52 participants at risk
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
|
|---|---|
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Cardiac disorders
Atrioventricular block first degree
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Cardiac disorders
Bundle branch block left
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Cardiac disorders
Sinus bradycardia
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Endocrine disorders
Goitre
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Diverticulum gastric
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
5.8%
3/52 • Number of events 3 • 3 months post-procedure
|
|
Gastrointestinal disorders
Gastric disorder
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.5%
6/52 • Number of events 6 • 3 months post-procedure
|
|
Gastrointestinal disorders
Hiatus hernia
|
3.8%
2/52 • Number of events 2 • 3 months post-procedure
|
|
Gastrointestinal disorders
Oesophageal disorder
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Oesophageal mucosa erythema
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Oesophageal polyp
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Infections and infestations
Oesophageal candidiasis
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Infections and infestations
Sinusitis
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal neoplasm
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Nervous system disorders
Cerebral ischaemia
|
11.5%
6/52 • Number of events 6 • 3 months post-procedure
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 3 • 3 months post-procedure
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Vascular disorders
Haematoma
|
9.6%
5/52 • Number of events 5 • 3 months post-procedure
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • 3 months post-procedure
|
Additional Information
Nathalie Macours / Clinical Research Director
Johnson and Johnson Medical NV/SA
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
- Publication restrictions are in place
Restriction type: OTHER