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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR)

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ClinicalTrials.gov Identifier: NCT01278953
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : February 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Paroxysmal Atrial Fibrillation
Intervention Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation
Enrollment 295
Recruitment Details  
Pre-assignment Details 300 subjects consented to study participation, 5 subjects did not have the study device introduced. Therefore 295 subjects contributed to study endpoints.
Arm/Group Title TactiCath Control
Hide Arm/Group Description

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Period Title: Overall Study
Started 155 145
Completed 146 134
Not Completed 9 11
Arm/Group Title TactiCath Control Total
Hide Arm/Group Description

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Total of all reporting groups
Overall Number of Baseline Participants 155 145 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 145 participants 300 participants
59.6  (9.32) 61  (10.84) 60.3  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 145 participants 300 participants
Female
55
  35.5%
54
  37.2%
109
  36.3%
Male
100
  64.5%
91
  62.8%
191
  63.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 145 participants 300 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.6%
0
   0.0%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.6%
0
   0.0%
1
   0.3%
White
148
  95.5%
141
  97.2%
289
  96.3%
More than one race
2
   1.3%
2
   1.4%
4
   1.3%
Unknown or Not Reported
3
   1.9%
2
   1.4%
5
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 145 participants 300 participants
United States 96 87 183
Europe 59 58 117
1.Primary Outcome
Title Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Hide Description Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TactiCath Control
Hide Arm/Group Description:

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: participants
99 93
2.Primary Outcome
Title Incidence of Device-related Early-onset Primary Serious Adverse Events
Hide Description Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TactiCath Control
Hide Arm/Group Description:

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Overall Number of Participants Analyzed 152 143
Measure Type: Number
Unit of Measure: participants
3 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TactiCath Control
Hide Arm/Group Description

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

All-Cause Mortality
TactiCath Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TactiCath Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/152 (6.58%)      11/143 (7.69%)    
Cardiac disorders     
Cardiac perforation   1/152 (0.66%)  1 0/143 (0.00%)  0
Atrial Perforation   0/152 (0.00%)  0 1/143 (0.70%)  1
General disorders     
Hospitalization   4/152 (2.63%)  4 5/143 (3.50%)  5
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema   2/152 (1.32%)  2 2/143 (1.40%)  2
Vascular disorders     
Vascular Access Complication   3/152 (1.97%)  3 3/143 (2.10%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TactiCath Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/152 (46.05%)      56/143 (39.16%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders   0/152 (0.00%)  0 1/143 (0.70%)  1
Cardiac disorders     
Cardiac disorders   38/152 (25.00%)  75 36/143 (25.17%)  59
Endocrine disorders     
Endocrine disorders   0/152 (0.00%)  0 1/143 (0.70%)  1
Eye disorders     
Eye disorders   0/152 (0.00%)  0 2/143 (1.40%)  4
Gastrointestinal disorders     
Gastrointestinal disorders   4/152 (2.63%)  4 4/143 (2.80%)  5
General disorders     
General disorders   6/152 (3.95%)  6 7/143 (4.90%)  8
Immune system disorders     
Immune system disorders   1/152 (0.66%)  1 1/143 (0.70%)  1
Infections and infestations     
Infection and infestations   4/152 (2.63%)  4 2/143 (1.40%)  2
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications   2/152 (1.32%)  2 3/143 (2.10%)  3
Investigations     
Investigations   6/152 (3.95%)  6 6/143 (4.20%)  8
Metabolism and nutrition disorders     
Metabolism and nutrition disorders   0/152 (0.00%)  0 3/143 (2.10%)  3
Musculoskeletal and connective tissue disorders     
Muskuloskeletal and connective disorders   2/152 (1.32%)  2 2/143 (1.40%)  2
Nervous system disorders     
Nervous systems disorders   7/152 (4.61%)  7 2/143 (1.40%)  4
Psychiatric disorders     
Psychiatric disorders   0/152 (0.00%)  0 1/143 (0.70%)  1
Renal and urinary disorders     
Renal and urinary disorders   4/152 (2.63%)  4 4/143 (2.80%)  4
Reproductive system and breast disorders     
Reproductive system and breast disorders   1/152 (0.66%)  1 0/143 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Repiratory, thoracic and mediastinal disorders   11/152 (7.24%)  11 3/143 (2.10%)  3
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders   2/152 (1.32%)  2 0/143 (0.00%)  0
Vascular disorders     
Vascular disorders   17/152 (11.18%)  20 9/143 (6.29%)  9
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Nicole Glowacki
Organization: St Jude Medical
Phone: 651-756-2000
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278953     History of Changes
Other Study ID Numbers: VP-002 527
First Submitted: January 17, 2011
First Posted: January 19, 2011
Results First Submitted: January 7, 2016
Results First Posted: February 8, 2016
Last Update Posted: March 8, 2016