NCT02817776: PRECEPT

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

Completed NA Results posted Last updated 4 February 2025

What this trial tests

NA trial testing THERMOCOOL SMARTTOUCH® SF catheter in Atrial Fibrillation in 381 participants. Completed in 5 June 2019.

Timeline

1 June 2016

Primary endpoint
5 June 2019

5 June 2019

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	381
Start date	1 June 2016
Primary completion	5 June 2019
Estimated completion	5 June 2019

Drugs / interventions tested

• THERMOCOOL SMARTTOUCH® SF catheter

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.

Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days Primary · 7 days (except as noted in analysis population description)

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

Group	Value	95% CI
Treatment Group	4.7

Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up Primary · 15-month follow-up

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

Group	Value	95% CI
Treatment Group	59.3

Acute Procedural Success Secondary · Immediate post-procedure

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

Group	Value	95% CI
Treatment Group	330

15-Month Single Procedure Success Secondary · 15-Month

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.

Group	Value	95% CI
Treatment Group	182

Early Onset Serious Adverse Event (SAE) Secondary · 7 days

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

Group	Value	95% CI
Treatment Group	33

Peri-Procedural Serious Adverse Event (SAE) Secondary · >7 to 30 days

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

Group	Value	95% CI
Treatment Group	6

Late Onset Serious Adverse Event (SAE) Secondary · >30 days up to 15 months

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

Group	Value	95% CI
Treatment Group	59

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group

Serious: 85/348 (24%)

Deaths: 2/348

Serious adverse events (139 terms)

Reaction	System	Treatment Group
Atrial Fribrillation	Cardiac disorders	—
Tachycardia	Cardiac disorders	—
Tachycardia	Cardiac disorders	—
Chest Pain	Cardiac disorders	—
Atrial flutter	Cardiac disorders	—
Cardiac Tamponade	Cardiac disorders	—
Pulmonary Edema (Respiratory Insufficiency)	Cardiac disorders	—
Chest Pain	Cardiac disorders	—
Atrial flutter	Cardiac disorders	—
Bradycardia	Cardiac disorders	—
Bradycardia	Cardiac disorders	—
Cardiac failure congestive	Cardiac disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Major Vascular Access Complication / Bleeding	Cardiac disorders	—
Sepsis	Infections and infestations	—
Cardiac Failure Congestive	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Pneumonia	Infections and infestations	—
Pericarditis	Cardiac disorders	—
Complication associated with urinary catheter	General disorders	—
Fluid overload	Metabolism and nutrition disorders	—
Pericardial Effusion	Cardiac disorders	—
Sepsis	Infections and infestations	—
Atrial flutter	Cardiac disorders	—

Most-reported serious reactions: Atrial Fribrillation, Tachycardia, Tachycardia, Chest Pain, Atrial flutter, Cardiac Tamponade, Pulmonary Edema (Respiratory Insufficiency), Chest Pain.

Data from ClinicalTrials.gov NCT02817776 adverse events section.

Sponsor's own description

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial.
   Mansour M, Calkins H, Osorio J, Pollak SJ, et al · · 2020 · cited 64× · PMID 32819531 · DOI 10.1016/j.jacep.2020.04.024
2. Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study.
   Natale A, Calkins H, Osorio J, Pollak SJ, et al · · 2021 · cited 16× · PMID 33290093 · DOI 10.1161/circep.120.008867
3. Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.
   Osorio J, Mansour M, Melby D, Imhoff RJ, et al · · 2022 · cited 2× · PMID 36589917 · DOI 10.1016/j.hroo.2022.09.011