Typical Atrial Flutter
Conditions
Brief summary
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
Detailed description
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Interventions
DEVICETherapy™ 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
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A signed written Informed Consent * Presence of typical atrial flutter (cavo-tricuspid isthmus dependent) * If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply * One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months * In good physical health * 18 years of age or older * Agree to comply with follow-up visits and evaluation
Exclusion criteria
* Prior typical atrial flutter ablation treatment * Pregnancy * Atypical flutter or scar flutter (non isthmus dependent) * Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment * A recent myocardial infarction within 3 months of the intended procedure date * Permanent coronary sinus pacing lead * Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve * Evidence of intra-cardiac thrombus or a history of clotting disorders * Participation in another investigational study * Cardiac surgery within 1 month prior to the intended procedure date * Allergy or contraindication to Heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure | 7 days | 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. |
| Primary Efficacy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 111 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants |
| Age, Continuous | 66.28 years STANDARD_DEVIATION 10.18 |
| Region of Enrollment Canada | 18 participants |
| Region of Enrollment United States | 182 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 179 |
| serious Total, serious adverse events | 5 / 179 |
Outcome results
Primary
Primary Efficacy
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.
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Efficacy | 177 participants |
Primary
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure | 5 participants |
Secondary
Secondary Efficacy
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Secondary Efficacy | 150 participants |