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Trial record 25 of 11644 for:    Contact

Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System (CONTACT_AFL)

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ClinicalTrials.gov Identifier: NCT01401361
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : December 23, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Typical Atrial Flutter
Intervention Device: Treatment Arm
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm
Hide Arm/Group Description Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Period Title: Overall Study
Started 150
Completed 122 [1]
Not Completed 28
Reason Not Completed
Withdrawal by Subject             16
Lack of Efficacy             6
Physician Decision             1
Lost to Follow-up             3
Subject/family decision post procedure             2
[1]
16 subjects were withdrawn prior to the use of the investigational device
Arm/Group Title Treatment Arm
Hide Arm/Group Description Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
<=18 years
0
   0.0%
Between 18 and 65 years
68
  45.3%
>=65 years
82
  54.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
64.82  (11.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
25
  16.7%
Male
125
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 150 participants
United States 140
Canada 10
1.Primary Outcome
Title Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure
Hide Description Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
3
2.Primary Outcome
Title Primary Efficacy
Hide Description Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
129
3.Secondary Outcome
Title Secondary Efficacy
Hide Description

Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,

1c, III) during the 3 months post ablation are considered chronic failures.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: participants
110
Time Frame [Not Specified]
Adverse Event Reporting Description 150 subjects who met Inc./Excl. criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 received the device. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%)
Total   3/134 (2.24%) 
Cardiac disorders   
Congestive Heart Failure   1/134 (0.75%) 
Intermittent High Grade AV Block   1/134 (0.75%) 
Nervous system disorders   
Transient Ischemic Attack   1/134 (0.75%) 
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 5%
Treatment Arm
Affected / at Risk (%)
Total   10/134 (7.46%) 
Cardiac disorders   
Arrhythmia   10/134 (7.46%) 
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
Layout table for Results Point of Contact information
Name/Title: Nancy Ouch
Organization: St. Jude Medical
Phone: +19497695041
EMail: NOuch@sjm.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01401361     History of Changes
Other Study ID Numbers: 90064772
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: November 4, 2013
Results First Posted: December 23, 2013
Last Update Posted: February 15, 2019