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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817776
Recruitment Status : Completed
First Posted : June 29, 2016
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Intervention Device: THERMOCOOL SMARTTOUCH® SF catheter
Enrollment 381
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Treatment Group
Hide Arm/Group Description Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Period Title: Overall Study
Started 381 [1]
Completed 293
Not Completed 88
Reason Not Completed
Excluded             33
Lost to Follow-up             20
Withdrawal by Subject             33
Death             2
[1]
33 excluded prior to procedure. 348 had study catheter inserted (Safety Population)
Arm/Group Title Treatment Group
Hide Arm/Group Description Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Baseline Participants 381
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants
65.6  (8.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants
Female
110
  28.9%
Male
271
  71.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants
Hispanic or Latino
7
   1.8%
Not Hispanic or Latino
357
  93.7%
Unknown or Not Reported
17
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
   1.6%
White
349
  91.6%
More than one race
0
   0.0%
Unknown or Not Reported
23
   6.0%
1.Primary Outcome
Title Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
Hide 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
Time Frame 7 days (except as noted in analysis population description)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 344
Measure Type: Number
Unit of Measure: Percentage of participants
4.7
2.Primary Outcome
Title Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
Hide Description

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
Time Frame 15-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 297
Measure Type: Number
Unit of Measure: Percentage of Participants
59.3
3.Secondary Outcome
Title Acute Procedural Success
Hide Description Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
Time Frame Immediate post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: Participants
330
4.Secondary Outcome
Title 15-Month Single Procedure Success
Hide Description 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.
Time Frame 15-Month
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population, n=333, minus 3 acute procedural failures and 36 missing outcomes not included in primary effectiveness endpoint calculation.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Participants
182
5.Secondary Outcome
Title Early Onset Serious Adverse Event (SAE)
Hide Description Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (number of subjects with study catheter inserted) was the analysis population for secondary safety endpoints.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 348
Measure Type: Number
Unit of Measure: Participants
33
6.Secondary Outcome
Title Peri-Procedural Serious Adverse Event (SAE)
Hide Description Peri-Procedural (>7 to 30 days) Serious Adverse Event
Time Frame >7 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (number of subjects with study catheter inserted)
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 348
Measure Type: Number
Unit of Measure: Participants
6
7.Secondary Outcome
Title Late Onset Serious Adverse Event (SAE)
Hide Description Occurrence of Late Onset (>30 days) Serious Adverse Event
Time Frame >30 days up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (number of subjects with study catheter inserted) and excluding subjects who exited prior to 30 days of follow up in the study.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Number of Participants Analyzed 346
Measure Type: Number
Unit of Measure: Participants
59
Time Frame 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group
Hide Arm/Group Description Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
All-Cause Mortality
Treatment Group
Affected / at Risk (%)
Total   2/348 (0.57%)    
Hide Serious Adverse Events
Treatment Group
Affected / at Risk (%) # Events
Total   85/348 (24.43%)    
Cardiac disorders   
Cardiac Tamponade   5/348 (1.44%)  5
Diaphragmatic Paralysis  [1]  1/348 (0.29%)  1
Pulmonary Edema (Respiratory Insufficiency)   5/348 (1.44%)  5
Pericarditis   2/348 (0.57%)  2
Major Vascular Access Complication / Bleeding   3/348 (0.86%)  3
Atrial Fribrillation  [2]  11/348 (3.16%)  13
Atrial Fibrillation  [3]  1/348 (0.29%)  1
Atrial Fibrillation  [4]  1/348 (0.29%)  1
Bradycardia  [5]  4/348 (1.15%)  4
Bradycardia  [6]  4/348 (1.15%)  4
Chest Pain  [5]  6/348 (1.72%)  7
Chest Pain  [4]  1/348 (0.29%)  1
Chest Pain  [6]  5/348 (1.44%)  6
Pericardial Effusion  [5]  2/348 (0.57%)  2
Pericardial Effusion  [4]  1/348 (0.29%)  1
Pericardial Effusion  [6]  1/348 (0.29%)  1
Tachycardia  [5]  11/348 (3.16%)  11
Tachycardia  [6]  10/348 (2.87%)  10
Tachycardia  [4]  1/348 (0.29%)  1
Torsade de pointes  [5]  1/348 (0.29%)  1
Torsade de pointes  [6]  1/348 (0.29%)  1
Atrial flutter  [5]  6/348 (1.72%)  7
Atrial flutter  [6]  5/348 (1.44%)  5
Atrial flutter  [3]  1/348 (0.29%)  1
Atrial flutter  [7]  1/348 (0.29%)  1
Atrial flutter  [4]  2/348 (0.57%)  2
Arrhythmia  [5]  2/348 (0.57%)  2
Arrhythmia  [4]  1/348 (0.29%)  1
Arrhythmia  [6]  1/348 (0.29%)  1
Atrioventricular block  [5]  1/348 (0.29%)  1
Atrioventricular block  [6]  1/348 (0.29%)  1
Cardiac Failure  [5]  1/348 (0.29%)  1
Cardiac Failure  [6]  1/348 (0.29%)  1
Cardiac failure congestive  [5]  4/348 (1.15%)  4
Cardiac Failure Congestive  [4]  1/348 (0.29%)  1
Cardiac Failure Congestive  [6]  3/348 (0.86%)  3
Coronary artery occlusion  [5]  1/348 (0.29%)  1
Coronary artery occlusion  [6]  1/348 (0.29%)  1
Myocardial infarction  [5]  2/348 (0.57%)  2
Myocardial infarction  [6]  2/348 (0.57%)  2
Ventricular extrasystoles  [5]  1/348 (0.29%)  1
Ventricular extrasystoles  [6]  1/348 (0.29%)  1
Ear and labyrinth disorders   
Vertigo  [5]  1/348 (0.29%)  1
Vertigo  [6]  1/348 (0.29%)  1
Eye disorders   
Diplopia  [5]  1/348 (0.29%)  1
Diplopia  [4]  1/348 (0.29%)  1
Gastrointestinal disorders   
Esophageal Ulcer  [8]  1/348 (0.29%)  1
Esophageal Ulcer  [7]  1/348 (0.29%)  1
Abdominal pain  [5]  1/348 (0.29%)  1
Abdominal pain  [6]  1/348 (0.29%)  1
Intra-abdominal hematoma  [5]  1/348 (0.29%)  1
Intra-abdominal hematoma  [6]  1/348 (0.29%)  1
Esophageal stenosis  [5]  1/348 (0.29%)  1
Esophageal stenosis  [6]  1/348 (0.29%)  1
Small intestinal obstruction  [5]  1/348 (0.29%)  1
Small intestinal obstruction  [6]  1/348 (0.29%)  1
General disorders   
Complication associated with urinary catheter  [9]  1/348 (0.29%)  1
Complication associated with urinary catheter  [10]  2/348 (0.57%)  3
Pyrexia  [5]  1/348 (0.29%)  1
Pyrexia  [6]  1/348 (0.29%)  1
Hepatobiliary disorders   
Cholecystitis  [5]  1/348 (0.29%)  1
Cholecystitis  [6]  1/348 (0.29%)  1
Immune system disorders   
Hypersensitivity  [5]  1/348 (0.29%)  1
Hypersensitivity  [6]  1/348 (0.29%)  1
Infections and infestations   
Sepsis  [5]  3/348 (0.86%)  3
Sepsis  [7]  1/348 (0.29%)  1
Sepsis  [6]  2/348 (0.57%)  2
Campylobacter gastroenteritis  [5]  1/348 (0.29%)  1
Campylobacter gastroenteritis  [6]  1/348 (0.29%)  1
Device related infection  [5]  1/348 (0.29%)  1
Device related infection  [6]  1/348 (0.29%)  1
Influenza  [5]  2/348 (0.57%)  2
Influenza  [6]  2/348 (0.57%)  2
Pneumonia  [5]  3/348 (0.86%)  3
Pneumonia  [6]  3/348 (0.86%)  3
Injury, poisoning and procedural complications   
Seroma  [5]  1/348 (0.29%)  1
Seroma  [6]  1/348 (0.29%)  1
Metabolism and nutrition disorders   
Fluid overload  [7]  2/348 (0.57%)  2
Obesity  [5]  1/348 (0.29%)  1
Obesity  [6]  1/348 (0.29%)  1
Fluid Overload  [5]  2/348 (0.57%)  2
Musculoskeletal and connective tissue disorders   
Back disorder  [5]  1/348 (0.29%)  1
Back disorder  [6]  1/348 (0.29%)  1
Back pain  [5]  1/348 (0.29%)  1
Back pain  [6]  1/348 (0.29%)  1
Femur Fracture  [5]  1/348 (0.29%)  1
Hip fracture  [5]  1/348 (0.29%)  1
Hip fracture  [6]  1/348 (0.29%)  1
Osteoarthritis  [5]  4/348 (1.15%)  4
Osteoarthritis  [6]  4/348 (1.15%)  4
Osteomyelitis  [5]  1/348 (0.29%)  1
Osteomyelitis  [6]  1/348 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon neoplasm  [5]  1/348 (0.29%)  1
Colon neoplasm  [6]  1/348 (0.29%)  1
Lung neoplasm malignant  [5]  1/348 (0.29%)  1
Lung neoplasm malignant  [6]  1/348 (0.29%)  1
Nervous system disorders   
Cerebrovascular Accident (CVA) / Stroke   1/348 (0.29%)  1
Presyncope  [5]  1/348 (0.29%)  1
Presyncope  [6]  1/348 (0.29%)  1
Syncope  [5]  1/348 (0.29%)  1
Syncope  [6]  1/348 (0.29%)  1
Tremor  [5]  1/348 (0.29%)  1
Tremor  [6]  1/348 (0.29%)  1
Cerebrovascular accident (CVA) / Stroke  [11]  1/348 (0.29%)  1
Psychiatric disorders   
Major depression  [5]  1/348 (0.29%)  1
Major depression  [6]  1/348 (0.29%)  1
Renal and urinary disorders   
Renal Failure  [5]  1/348 (0.29%)  1
Renal Failure  [4]  1/348 (0.29%)  1
Urinary tract infection  [5]  1/348 (0.29%)  1
Urinary tract infection  [4]  1/348 (0.29%)  1
Hematuria  [5]  1/348 (0.29%)  1
Hematuria  [6]  1/348 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  [5]  1/348 (0.29%)  1
Hypoxia  [4]  1/348 (0.29%)  1
Pleural effusion  [5]  2/348 (0.57%)  2
Pleural effusion  [4]  1/348 (0.29%)  1
Pleural effusion  [6]  1/348 (0.29%)  1
Pulmonary embolism  [5]  2/348 (0.57%)  2
Pulmonary embolism  [4]  1/348 (0.29%)  1
Pulmonary embolism  [6]  1/348 (0.29%)  1
Tuberculosis  [6]  1/348 (0.29%)  1
Tuberculosis  [5]  1/348 (0.29%)  1
Bronchitis viral  [5]  1/348 (0.29%)  1
Bronchitis viral  [6]  1/348 (0.29%)  1
Chronic obstructive pulmonary disease  [5]  1/348 (0.29%)  1
Chronic obstructive pulmonary disease  [6]  1/348 (0.29%)  1
Respiratory failure  [5]  2/348 (0.57%)  2
Respiratory failure  [6]  2/348 (0.57%)  2
Dyspnea  [5]  2/348 (0.57%)  2
Dyspnea  [4]  1/348 (0.29%)  1
Dyspnea  [6]  1/348 (0.29%)  1
Skin and subcutaneous tissue disorders   
Cellulitis  [5]  1/348 (0.29%)  1
Cellulitis  [6]  1/348 (0.29%)  1
Squamous cell cercinoma  [5]  1/348 (0.29%)  1
Squamous cell cercinoma  [6]  1/348 (0.29%)  1
Vascular disorders   
Hypertensive Crisis  [5]  1/348 (0.29%)  1
Hypertensive Crisis  [6]  1/348 (0.29%)  1
Hemorrhage  [5]  2/348 (0.57%)  2
Hemorrhage  [6]  2/348 (0.57%)  2
Indicates events were collected by systematic assessment
[1]
Possibly device related and possibly procedure related
[2]
Not Device Related and Not Procedure Related
[3]
Possibly device related
[4]
Possibly procedure related
[5]
Not device related
[6]
Not procedure related
[7]
Definitely procedure related
[8]
Definitely device related
[9]
Possibly procedure related, not device related
[10]
Definitely procedure related, not device related
[11]
Not procedure or device related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group
Affected / at Risk (%) # Events
Total   0/348 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kendra McInnis
Organization: Biosense Webster Inc
Phone: +1 949 322-8010
EMail: kmcinnis@its.jnj.com
Layout table for additonal information
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT02817776    
Other Study ID Numbers: STSF-159
First Submitted: June 27, 2016
First Posted: June 29, 2016
Results First Submitted: October 30, 2020
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021