Trial Outcomes & Findings for SMART China, A Multi-center Clinical Registry Study (NCT NCT02485925)
NCT ID: NCT02485925
Last Updated: 2025-02-04
Results Overview
The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
12 Months
Results posted on
2025-02-04
Participant Flow
A total of 201 patients from 12 sites in China were screened and 200 patients were enrolled into the study.
This was a prospective, multicenter, non-randomized clinical study. Patients were enrolled to receive THERMOCOOL® SMARTTOUCHTM catheter if signed informed consent forms and satisfied the study inclusion and exclusion criteria.
Participant milestones
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
Safety Population
|
200
|
|
Overall Study
Intent to Treat (ITT) Population
|
193
|
|
Overall Study
Per-Protocol Population
|
166
|
|
Overall Study
COMPLETED
|
185
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
11
|
Baseline Characteristics
All enrolled subjects
Baseline characteristics by cohort
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=200 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Age, Continuous
|
61.2 Years
STANDARD_DEVIATION 9.25 • n=5 Participants • All enrolled subjects
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants • All enrolled subjects
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants • All enrolled subjects
|
|
Race/Ethnicity, Customized
Han Nationality
|
198 Participants
n=5 Participants • All enrolled subjects
|
|
Race/Ethnicity, Customized
Others: Hui Nationality
|
2 Participants
n=5 Participants • All enrolled subjects
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Per protocol population: Subjects in the ITT Population who undergone insertion of the study catheter and AF ablation procedure, and had the 12th month primary efficacy endpoint data.
The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=166 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
|
80.7 Percentage of Participants
Interval 73.9 to 86.4
|
SECONDARY outcome
Timeframe: 0.5 hoursPopulation: Safety Population, i.e., all enrolled subjects who undergone insertion of the study catheter during the procedure
Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=200 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Percentage of Patients Where Acute Success Was Achieved
|
99.5 Percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: 1 day during procedurePopulation: Safety population with contact force data available
Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=198 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Average Contact Force Per Pulmonary Vein Ablation Procedure
|
12.9 Grams
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: 1 day during procedurePopulation: Safety population with pulmonary vein reconnection data available
Percentage of subjects with PV reconnection after the first ablation
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=199 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
|
7.5 Percentage of participants
Interval 4.3 to 12.1
|
SECONDARY outcome
Timeframe: 1 day during procedurePopulation: Safety population
Procedure Time, Ablation Time and Fluoroscopy Time in minutes
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=200 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Procedure Time, Ablation Time and Fluoroscopy Time
Duration of Procedure (min)
|
144.5 Minutes
Standard Deviation 41.28
|
|
Procedure Time, Ablation Time and Fluoroscopy Time
Duration of Ablation (min)
|
63.5 Minutes
Standard Deviation 36.15
|
|
Procedure Time, Ablation Time and Fluoroscopy Time
Total Duration of Fluoroscopy (min)
|
15.6 Minutes
Standard Deviation 10.02
|
Adverse Events
THERMOCOOL® SMARTTOUCH™ Family of Catheters
Serious events: 26 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=200 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Number of events 2 • 12 months after ablation procedure
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
3/200 • Number of events 3 • 12 months after ablation procedure
|
|
Infections and infestations
Pneumonia
|
1.5%
3/200 • Number of events 4 • 12 months after ablation procedure
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.0%
2/200 • Number of events 2 • 12 months after ablation procedure
|
|
Vascular disorders
Arteriovenous fistula
|
1.0%
2/200 • Number of events 2 • 12 months after ablation procedure
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Cardiac tamponade
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Coronary heart disease
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Sinus bradycardia
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Sinus node dysfunction
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Syncope
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Infections and infestations
Lung infection
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Infections and infestations
Sepsis
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Deep vein thrombosis
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Ischaemia
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Injury, poisoning and procedural complications
Gas poisoning
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Investigations
Arteriogram coronary
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
Other adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Family of Catheters
n=200 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Arteriovenous fistula
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
General disorders
Chest discomfort
|
1.5%
3/200 • Number of events 3 • 12 months after ablation procedure
|
|
General disorders
Chest pain
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Ecchymosis
|
1.5%
3/200 • Number of events 3 • 12 months after ablation procedure
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Vascular disorders
Haematoma
|
1.0%
2/200 • Number of events 2 • 12 months after ablation procedure
|
|
Gastrointestinal disorders
Nausea
|
3.0%
6/200 • Number of events 6 • 12 months after ablation procedure
|
|
Investigations
Neutrophil count increased
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Palpitations
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
2/200 • Number of events 2 • 12 months after ablation procedure
|
|
General disorders
Pyrexia
|
3.0%
6/200 • Number of events 6 • 12 months after ablation procedure
|
|
Vascular disorders
Vessel puncture site haematoma
|
1.5%
3/200 • Number of events 3 • 12 months after ablation procedure
|
|
Vascular disorders
Vessel puncture site haemorrhage
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/200 • Number of events 4 • 12 months after ablation procedure
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.50%
1/200 • Number of events 1 • 12 months after ablation procedure
|
Additional Information
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