Trial Outcomes & Findings for Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro) (NCT NCT02944968)
NCT ID: NCT02944968
Last Updated: 2025-02-04
Results Overview
Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Day of ablation procedure
Results posted on
2025-02-04
Participant Flow
A total of 51 subjects were enrolled in the study at 6 sites in Europe. The first subject was enrolled on September 28th, 2016 and the last subject was enrolled on April 26th, 2018.
Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects had pre-procedure imaging to screen for the presence of left atrial appendage thrombus to decrease the potential for thromboembolic complications.
Participant milestones
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Overall Study
Subject excluded before study procedure
|
1
|
|
Overall Study
Subject didn't meet eligibility criteria
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
n=51 Participants
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 11.92 • n=51 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=51 Participants
|
|
Region of Enrollment
European Union
|
51 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day of ablation procedurePopulation: This total effectiveness outcome population includes all subjects (under both protocols v1.0 and v2.0), complied with study inclusion and exclusion criteria, received investigational device, and had an adenosine challenge applied for verifying entrance block.
Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
Outcome measures
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
n=47 Participants
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Subjects with entrance block confirmation
|
46 Participants
|
|
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Subjects without entrance block confirmation
|
1 Participants
|
SECONDARY outcome
Timeframe: Seven Days Post ProcedurePopulation: Total Safety Population: includes subjects enrolled under CIP v1.0 and 2.0 who underwent study procedure with investigational device.
Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula
Outcome measures
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
n=50 Participants
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Subjects with Pericard. effusion without tamponade
|
1 Participants
|
|
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Subjects with Pericarditis
|
1 Participants
|
|
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Subjects with Vascular pseudoaneurysm
|
1 Participants
|
|
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Subjects without primary adverse events
|
47 Participants
|
Adverse Events
THERMOCOOL SMARTTOUCH® SF-5D
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
n=50 participants at risk
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Infections and infestations
Influenza
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Infections and infestations
Localised infection
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
Other adverse events
| Measure |
THERMOCOOL SMARTTOUCH® SF-5D
n=50 participants at risk
The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Atrial tachycardia
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50 • Number of events 2 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Endocrine disorders
Thyroid disorder
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Eye disorders
Visual impairment
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
General disorders
Chest pain
|
12.0%
6/50 • Number of events 6 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
General disorders
Malaise
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Infections and infestations
Influenza
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
4/50 • Number of events 4 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Vascular disorders
Haematoma
|
10.0%
5/50 • Number of events 5 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
General disorders
Perforation
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.0%
1/50 • Number of events 1 • Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
|
Additional Information
Nathalie Macours, Clinical Research Director
Johnson and Johnson Medical NV/SA
Phone: +32 2 746 35 27
Email: [email protected]
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