Trial Outcomes & Findings for Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF) (NCT NCT02817776)

Last Updated: 2025-02-04

Results Overview

The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: * Death * Atrio-esophageal fistula\* * Cardiac Tamponade\*\*+/Perforation+ * Myocardial infarction (MI) * Stroke / Cerebrovascular accident (CVA) †, †† * Thromboembolism * Transient Ischemic Attack * Diaphragmatic paralysis * Pneumothorax * Heart block * PV stenosis\* * Pulmonary edema (Respiratory Insufficiency) * Pericarditis * Major Vascular access complication / bleeding

Recruitment status

COMPLETED

Study phase

Target enrollment

381 participants

Primary outcome timeframe

7 days (except as noted in analysis population description)

Results posted on

2025-02-04

Participant Flow

Total of 367 subjects were proposed in the protocol to be enrolled for this study. The enrollment had been completed and closed after reaching a total of 381 enrolled subjects. The last subject was enrolled on February 6th, 2018.

Participant milestones

Participant milestones
Measure	Treatment Group Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Study STARTED	381
Overall Study COMPLETED	293
Overall Study NOT COMPLETED	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Study Excluded	33
Overall Study Lost to Follow-up	20
Overall Study Withdrawal by Subject	33
Overall Study Death	2

Baseline Characteristics

Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=381 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Age, Continuous	65.6 Years STANDARD_DEVIATION 8.72 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	271 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	357 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	349 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days (except as noted in analysis population description)

Population: The safety population was used as the primary analysis population. Subjects with missing 3-month follow-up were excluded from the primary analysis unless the subjects experienced a Primary AE prior to the 3-month visit post-procedure. PV stenosis and AE fistula that occurred \> 1 week and cardiac tamponade/perforation that occurred up to 30 days post ablation were also deemed Primary AEs.

Outcome measures

Outcome measures
Measure	Treatment Group n=344 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days	4.7 Percentage of participants

PRIMARY outcome

Timeframe: 15-month follow-up

Population: The PP population was used as the primary analysis population. Subjects who did not complete the 15-month follow-up were considered missing and were excluded from the primary analysis unless the subjects experienced effectiveness failure prior to exiting the study.

The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: * Acute Procedural Failure * Non-Study Catheter Failure * Repeat Ablation Failure * AAD Failure * Surgical Failure

Outcome measures

Outcome measures
Measure	Treatment Group n=297 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up	59.3 Percentage of Participants

SECONDARY outcome

Timeframe: Immediate post-procedure

Population: Per Protocol Population

Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.

Outcome measures

Outcome measures
Measure	Treatment Group n=333 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Acute Procedural Success	330 Participants

SECONDARY outcome

Timeframe: 15-Month

Population: Per Protocol Population, n=333, minus 3 acute procedural failures and 36 missing outcomes not included in primary effectiveness endpoint calculation.

The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes \> 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.

Outcome measures

Outcome measures
Measure	Treatment Group n=294 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
15-Month Single Procedure Success	182 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Safety Population (number of subjects with study catheter inserted) was the analysis population for secondary safety endpoints.

Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event

Outcome measures

Outcome measures
Measure	Treatment Group n=348 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Early Onset Serious Adverse Event (SAE)	33 Participants

SECONDARY outcome

Timeframe: >7 to 30 days

Population: Safety Population (number of subjects with study catheter inserted)

Peri-Procedural (\>7 to 30 days) Serious Adverse Event

Outcome measures

Outcome measures
Measure	Treatment Group n=348 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Peri-Procedural Serious Adverse Event (SAE)	6 Participants

SECONDARY outcome

Timeframe: >30 days up to 15 months

Population: Safety Population (number of subjects with study catheter inserted) and excluding subjects who exited prior to 30 days of follow up in the study.

Occurrence of Late Onset (\>30 days) Serious Adverse Event

Outcome measures

Outcome measures
Measure	Treatment Group n=346 Participants Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Late Onset Serious Adverse Event (SAE)	59 Participants

Adverse Events

Treatment Group

Serious events: 85 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=348 participants at risk Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Cardiac disorders Cardiac Tamponade	1.4% 5/348 • Number of events 5 • 15 months
Nervous system disorders Cerebrovascular Accident (CVA) / Stroke	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Diaphragmatic Paralysis	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Pulmonary Edema (Respiratory Insufficiency)	1.4% 5/348 • Number of events 5 • 15 months
Cardiac disorders Pericarditis	0.57% 2/348 • Number of events 2 • 15 months
Cardiac disorders Major Vascular Access Complication / Bleeding	0.86% 3/348 • Number of events 3 • 15 months
Cardiac disorders Atrial Fribrillation	3.2% 11/348 • Number of events 13 • 15 months
Cardiac disorders Atrial Fibrillation	0.29% 1/348 • Number of events 1 • 15 months
Gastrointestinal disorders Esophageal Ulcer	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Bradycardia	1.1% 4/348 • Number of events 4 • 15 months
Cardiac disorders Chest Pain	1.4% 5/348 • Number of events 6 • 15 months
General disorders Complication associated with urinary catheter	0.57% 2/348 • Number of events 3 • 15 months
Eye disorders Diplopia	0.29% 1/348 • Number of events 1 • 15 months
Metabolism and nutrition disorders Fluid overload	0.57% 2/348 • Number of events 2 • 15 months
Vascular disorders Hypertensive Crisis	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Pericardial Effusion	0.29% 1/348 • Number of events 1 • 15 months
General disorders Pyrexia	0.29% 1/348 • Number of events 1 • 15 months
Renal and urinary disorders Renal Failure	0.29% 1/348 • Number of events 1 • 15 months
Infections and infestations Sepsis	0.57% 2/348 • Number of events 2 • 15 months
Cardiac disorders Tachycardia	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Torsade de pointes	0.29% 1/348 • Number of events 1 • 15 months
Renal and urinary disorders Urinary tract infection	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Atrial flutter	0.57% 2/348 • Number of events 2 • 15 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.29% 1/348 • Number of events 1 • 15 months
Nervous system disorders Presyncope	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Tuberculosis	0.29% 1/348 • Number of events 1 • 15 months
Gastrointestinal disorders Abdominal pain	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Arrhythmia	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Atrioventricular block	0.29% 1/348 • Number of events 1 • 15 months
Musculoskeletal and connective tissue disorders Back disorder	0.29% 1/348 • Number of events 1 • 15 months
Musculoskeletal and connective tissue disorders Back pain	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Bronchitis viral	0.29% 1/348 • Number of events 1 • 15 months
Infections and infestations Campylobacter gastroenteritis	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Cardiac Failure	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Cardiac failure congestive	1.1% 4/348 • Number of events 4 • 15 months
Cardiac disorders Cardiac Failure Congestive	0.86% 3/348 • Number of events 3 • 15 months
Skin and subcutaneous tissue disorders Cellulitis	0.29% 1/348 • Number of events 1 • 15 months
Hepatobiliary disorders Cholecystitis	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.29% 1/348 • Number of events 1 • 15 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Coronary artery occlusion	0.29% 1/348 • Number of events 1 • 15 months
Infections and infestations Device related infection	0.29% 1/348 • Number of events 1 • 15 months
Musculoskeletal and connective tissue disorders Femur Fracture	0.29% 1/348 • Number of events 1 • 15 months
Renal and urinary disorders Hematuria	0.29% 1/348 • Number of events 1 • 15 months
Vascular disorders Hemorrhage	0.57% 2/348 • Number of events 2 • 15 months
Musculoskeletal and connective tissue disorders Hip fracture	0.29% 1/348 • Number of events 1 • 15 months
Immune system disorders Hypersensitivity	0.29% 1/348 • Number of events 1 • 15 months
Infections and infestations Influenza	0.57% 2/348 • Number of events 2 • 15 months
Gastrointestinal disorders Intra-abdominal hematoma	0.29% 1/348 • Number of events 1 • 15 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.29% 1/348 • Number of events 1 • 15 months
Psychiatric disorders Major depression	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Myocardial infarction	0.57% 2/348 • Number of events 2 • 15 months
Metabolism and nutrition disorders Obesity	0.29% 1/348 • Number of events 1 • 15 months
Gastrointestinal disorders Esophageal stenosis	0.29% 1/348 • Number of events 1 • 15 months
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 4/348 • Number of events 4 • 15 months
Musculoskeletal and connective tissue disorders Osteomyelitis	0.29% 1/348 • Number of events 1 • 15 months
Infections and infestations Pneumonia	0.86% 3/348 • Number of events 3 • 15 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.57% 2/348 • Number of events 2 • 15 months
Injury, poisoning and procedural complications Seroma	0.29% 1/348 • Number of events 1 • 15 months
Gastrointestinal disorders Small intestinal obstruction	0.29% 1/348 • Number of events 1 • 15 months
Skin and subcutaneous tissue disorders Squamous cell cercinoma	0.29% 1/348 • Number of events 1 • 15 months
Nervous system disorders Syncope	0.29% 1/348 • Number of events 1 • 15 months
Nervous system disorders Tremor	0.29% 1/348 • Number of events 1 • 15 months
Cardiac disorders Ventricular extrasystoles	0.29% 1/348 • Number of events 1 • 15 months
Ear and labyrinth disorders Vertigo	0.29% 1/348 • Number of events 1 • 15 months
Respiratory, thoracic and mediastinal disorders Dyspnea	0.29% 1/348 • Number of events 1 • 15 months
Metabolism and nutrition disorders Fluid Overload	0.57% 2/348 • Number of events 2 • 15 months
Nervous system disorders Cerebrovascular accident (CVA) / Stroke	0.29% 1/348 • Number of events 1 • 15 months

Other adverse events

Adverse event data not reported

Additional Information

Kendra McInnis

Biosense Webster Inc

Phone: +1 949 322-8010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place