Trial Outcomes & Findings for Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System (NCT NCT01401361)

NCT ID: NCT01401361

Last Updated: 2019-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	Treatment Arm 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 Study STARTED	150
Overall Study COMPLETED	122
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Measure	Treatment Arm 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 Study Withdrawal by Subject	16
Overall Study Lack of Efficacy	6
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	3
Overall Study Subject/family decision post procedure	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Arm n=150 Participants 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 .
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants
Age, Categorical >=65 years	82 Participants n=5 Participants
Age, Continuous	64.82 years STANDARD_DEVIATION 11.97 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants
Region of Enrollment United States	140 participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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.

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.

Outcome measures

Measure	Treatment Arm n=134 Participants 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 .
Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure	3 participants

PRIMARY outcome

Timeframe: 30 minutes

Population: 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.

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.

Outcome measures

Measure	Treatment Arm n=133 Participants 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 .
Primary Efficacy	129 participants

SECONDARY outcome

Timeframe: 3 months

Population: 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).

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.

Outcome measures

Measure	Treatment Arm n=124 Participants 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 .
Secondary Efficacy	110 participants

Adverse Events

Treatment Arm

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=134 participants at risk 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 .
Cardiac disorders Congestive Heart Failure	0.75% 1/134 150 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.
Cardiac disorders Intermittent High Grade AV Block	0.75% 1/134 150 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.
Nervous system disorders Transient Ischemic Attack	0.75% 1/134 150 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.

Other adverse events

Measure	Treatment Arm n=134 participants at risk 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 .
Cardiac disorders Arrhythmia	7.5% 10/134 150 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.

Additional Information

Nancy Ouch

St. Jude Medical

Phone: +19497695041

Email: NOuch@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER