Trial Outcomes & Findings for SMART-SF Radiofrequency Ablation Safety Study (NCT NCT02359890)

Last Updated: 2025-02-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

165 participants

Primary outcome timeframe

Seven days post ablation procedure

Results posted on

2025-02-04

Participant Flow

This study enrolled 165 subjects at 17 clinical sites in the U.S. over approximately 5 months. The first subject was enrolled on March 30, 2015 and the last subject was enrolled on September 9, 2015. The last ablation procedure was on September 17, 2015. The last 1-month follow-up visit occurred on November 3, 2015.

Participant milestones

Participant milestones
Measure	THERMOCOOL SMARTTOUCH® SF Family of Catheters Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Overall Study STARTED	165
Overall Study Safety Population	159
Overall Study mITT Population	155
Overall Study Per-Protocol (PP) Population	155
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	THERMOCOOL SMARTTOUCH® SF Family of Catheters Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Overall Study Not meeting eligibility	4
Overall Study Never treated with study catheter	6

Baseline Characteristics

SMART-SF Radiofrequency Ablation Safety Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	THERMOCOOL SMARTTOUCH® SF Family of Catheters n=164 Participants Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Age, Continuous Age (Years)	62.7 Years STANDARD_DEVIATION 10.44 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	159 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Seven days post ablation procedure

Population: The modified intent-to-treat (mITT) population was used, which consisted of enrolled subjects who met the eligibility criteria and had the study catheter inserted.

Outcome measures

Outcome measures
Measure	THERMOCOOL SMARTTOUCH® SF Catheters n=155 Participants Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Percentage of Participants With Early Onset Primary Adverse Events	2.6 Percentage of participants Interval 0.7 to 6.5

SECONDARY outcome

Timeframe: Up to 30 days post Procedure

Population: Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.

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

Outcome measures

Outcome measures
Measure	THERMOCOOL SMARTTOUCH® SF Catheters n=159 Participants Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) Patients with SAE within 7 days post procedure	3.1 Percentage of Participants
Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) Patients with SAE during 8-30 days post-procedure	0.6 Percentage of Participants

SECONDARY outcome

Timeframe: End of procedure

Population: Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.

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

Outcome measures

Outcome measures
Measure	THERMOCOOL SMARTTOUCH® SF Catheters n=159 Participants Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Percentage of Participants With Acute Success	96.2 Percentage of participants Interval 92.0 to 98.6

SECONDARY outcome

Timeframe: 12 months

Population: Effectiveness per Protocol Population, which is defined as enrolled subjects who underwent RF ablation procedure with study catheter and completed the 12 month visit.

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

Outcome measures

Outcome measures
Measure	THERMOCOOL SMARTTOUCH® SF Catheters n=76 Participants Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)	75 Percentage of Participants Interval 65.5 to 83.0

Adverse Events

THERMOCOOL SMARTTOUCH® SF Family of Catheters

Serious events: 9 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	THERMOCOOL SMARTTOUCH® SF Family of Catheters n=159 participants at risk Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Infections and infestations Sepsis due to urinary tract and upper respiratory infection	0.63% 1/159 • Number of events 1 • 30 days post procedure
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.63% 1/159 • Number of events 1 • 30 days post procedure
Eye disorders Hospitalization due to transient neurological symptoms	0.63% 1/159 • Number of events 1 • 30 days post procedure
Gastrointestinal disorders Abdominal pain/nausea/constipation	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Atrial fibrillation with rapid ventricular response	0.63% 1/159 • Number of events 1 • 30 days post procedure
Respiratory, thoracic and mediastinal disorders Septic shock due to pneumonia with abscess	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Cardiac Tamponade	1.3% 2/159 • Number of events 2 • 30 days post procedure
Nervous system disorders Transient Ischemic Attack	0.63% 1/159 • Number of events 1 • 30 days post procedure
General disorders Thromboembolism	0.63% 1/159 • Number of events 1 • 30 days post procedure

Other adverse events

Other adverse events
Measure	THERMOCOOL SMARTTOUCH® SF Family of Catheters n=159 participants at risk Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Vascular disorders Groin hematoma	1.9% 3/159 • Number of events 3 • 30 days post procedure
Vascular disorders Hypotension	0.63% 1/159 • Number of events 1 • 30 days post procedure
Infections and infestations Cellulitis	0.63% 1/159 • Number of events 1 • 30 days post procedure
Infections and infestations UTI	0.63% 1/159 • Number of events 1 • 30 days post procedure
Infections and infestations Tooth infection	0.63% 1/159 • Number of events 1 • 30 days post procedure
General disorders Globus feeling in pharynx	0.63% 1/159 • Number of events 1 • 30 days post procedure
General disorders Chest pressure	0.63% 1/159 • Number of events 1 • 30 days post procedure
General disorders Catheter site edema	0.63% 1/159 • Number of events 1 • 30 days post procedure
General disorders Fatigue	3.8% 6/159 • Number of events 6 • 30 days post procedure
General disorders Radiating chest pain	1.3% 2/159 • Number of events 2 • 30 days post procedure
General disorders Chest pain/discomfort	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Pericarditis	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Atrial Flutter	2.5% 4/159 • Number of events 4 • 30 days post procedure
Cardiac disorders Atrial Tachycardia	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Paroxysmal SVT	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Atypical left atrial flutter	0.63% 1/159 • Number of events 1 • 30 days post procedure
Cardiac disorders Shock	0.63% 1/159 • Number of events 1 • 30 days post procedure
Gastrointestinal disorders Nausea	0.63% 1/159 • Number of events 1 • 30 days post procedure
Metabolism and nutrition disorders Fluid retention	0.63% 1/159 • Number of events 1 • 30 days post procedure
Nervous system disorders Numbness in feet	0.63% 1/159 • Number of events 1 • 30 days post procedure
Nervous system disorders Lightheadedness	0.63% 1/159 • Number of events 1 • 30 days post procedure
Respiratory, thoracic and mediastinal disorders Cough	0.63% 1/159 • Number of events 1 • 30 days post procedure
Respiratory, thoracic and mediastinal disorders Shortness of breath	1.3% 2/159 • Number of events 2 • 30 days post procedure
Respiratory, thoracic and mediastinal disorders Dyspnea	0.63% 1/159 • Number of events 1 • 30 days post procedure
Injury, poisoning and procedural complications Dizziness	0.63% 1/159 • Number of events 1 • 30 days post procedure
Injury, poisoning and procedural complications Poison ivy exposure	0.63% 1/159 • Number of events 1 • 30 days post procedure
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.63% 1/159 • Number of events 1 • 30 days post procedure

Additional Information

Robert Stagg

Biosense Webster

Phone: (800) 729-9010

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