Trial Outcomes & Findings for Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter (NCT NCT01408485)

NCT ID: NCT01408485

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: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	Treatment Arm Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Overall Study STARTED	200
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	Treatment Arm Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Overall Study Withdrawal by Subject	21

Baseline Characteristics

Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

Baseline characteristics by cohort

Measure	Treatment Arm n=200 Participants Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Age, Continuous	66.28 years STANDARD_DEVIATION 10.18 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants
Age, Categorical >=65 years	111 Participants n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=5 Participants
Region of Enrollment United States	182 participants n=5 Participants
Region of Enrollment Canada	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of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=179 Participants Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure	5 participants

PRIMARY outcome

Timeframe: 30 minutes

Primary efficacy or acute success is defined as achievement of bi-directional 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=179 Participants Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Primary Efficacy	177 participants

SECONDARY outcome

Timeframe: 3 months

Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.

Outcome measures

Measure	Treatment Arm n=175 Participants Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Secondary Efficacy	150 participants

Adverse Events

Treatment Arm

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=179 participants at risk Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Cardiac disorders Congestive Heart Failure	1.1% 2/179 • Number of events 2 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 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 Arrythmia	0.56% 1/179 • Number of events 1 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 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.
General disorders Other	0.56% 1/179 • Number of events 1 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 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 Stroke/Cerebrovascular Accident	0.56% 1/179 • Number of events 1 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 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=179 participants at risk Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
Cardiac disorders Palpitations	5.0% 9/179 • Number of events 9 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 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, Senior Clinical Project Manager

St. Jude Medical

Phone: 949-769-5000

Email: NOuch@sjm.com

Results disclosure agreements

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

Restriction type: OTHER