NCT02359890

SMART-SF Radiofrequency Ablation Safety Study

Completed Phase 3 Results posted Last updated 4 February 2025

What this trial tests

Phase 3 trial testing THERMOCOOL® SMARTTOUCH® (RF ablation treatment) in Atrial Fibrillation in 165 participants. Completed in 8 November 2016.

Timeline

1 March 2015

Primary endpoint
1 September 2015

8 November 2016

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	165
Start date	1 March 2015
Primary completion	1 September 2015
Estimated completion	8 November 2016

Drugs / interventions tested

• THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Early Onset Primary Adverse Events Primary · Seven days post ablation procedure

Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.

Group	Value	95% CI
THERMOCOOL SMARTTOUCH® SF Catheters	2.6	0.7 – 6.5

Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) Secondary · Up to 30 days post Procedure

This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure

Patients with SAE within 7 days post procedure

Group	Value	95% CI
THERMOCOOL SMARTTOUCH® SF Catheters	3.1

Patients with SAE during 8-30 days post-procedure

Group	Value	95% CI
THERMOCOOL SMARTTOUCH® SF Catheters	0.6

Percentage of Participants With Acute Success Secondary · End of procedure

Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).

Group	Value	95% CI
THERMOCOOL SMARTTOUCH® SF Catheters	96.2	92.0 – 98.6

Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL) Secondary · 12 months

The freedom from documented AF/AT/AFL based on electrocardiographic data

Group	Value	95% CI
THERMOCOOL SMARTTOUCH® SF Catheters	75	65.5 – 83.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days post procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

THERMOCOOL SMARTTOUCH® SF Family of Catheters

Serious: 9/159 (6%)

Deaths: —

Serious adverse events (9 terms)

Reaction	System	THERMOCOOL SMARTTOUCH® SF …
Cardiac Tamponade	Cardiac disorders	—
Sepsis due to urinary tract and upper respiratory infection	Infections and infestations	—
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	—
Hospitalization due to transient neurological symptoms	Eye disorders	—
Abdominal pain/nausea/constipation	Gastrointestinal disorders	—
Atrial fibrillation with rapid ventricular response	Cardiac disorders	—
Septic shock due to pneumonia with abscess	Respiratory, thoracic and mediastinal disorders	—
Transient Ischemic Attack	Nervous system disorders	—
Thromboembolism	General disorders	—

Other adverse events (27 terms — click to expand)

Reaction	System	THERMOCOOL SMARTTOUCH® SF …
Fatigue	General disorders	—
Atrial Flutter	Cardiac disorders	—
Groin hematoma	Vascular disorders	—
Radiating chest pain	General disorders	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—
Cellulitis	Infections and infestations	—
UTI	Infections and infestations	—
Tooth infection	Infections and infestations	—
Globus feeling in pharynx	General disorders	—
Chest pressure	General disorders	—
Catheter site edema	General disorders	—
Chest pain/discomfort	General disorders	—
Pericarditis	Cardiac disorders	—
Atrial Tachycardia	Cardiac disorders	—
Paroxysmal SVT	Cardiac disorders	—
Atypical left atrial flutter	Cardiac disorders	—
Shock	Cardiac disorders	—
Nausea	Gastrointestinal disorders	—
Fluid retention	Metabolism and nutrition disorders	—
Numbness in feet	Nervous system disorders	—
Lightheadedness	Nervous system disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Dizziness	Injury, poisoning and procedural complications	—
Poison ivy exposure	Injury, poisoning and procedural complications	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Cardiac Tamponade, Sepsis due to urinary tract and upper respiratory infection, Aspiration pneumonia, Hospitalization due to transient neurological symptoms, Abdominal pain/nausea/constipation, Atrial fibrillation with rapid ventricular response, Septic shock due to pneumonia with abscess, Transient Ischemic Attack.

Data from ClinicalTrials.gov NCT02359890 adverse events section.

Sponsor's own description

This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. QDOT MICRO™ versus THERMOCOOL^® SMARTTOUCH™ and THERMOCOOL SMARTTOUCH^® Surround Flow in radiofrequency ablation of paroxysmal atrial fibrillation.
   Osorio J, Maccioni S, Sharma R, Patel L, et al · · 2023 · PMID 37584396 · DOI 10.57264/cer-2023-0005