Typical Atrial Flutter
Conditions
Brief summary
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result into unacceptable risk of intra-procedural composite serious adverse events and, * Does not affect efficacy of the ablation procedure The study will also evaluate the
Detailed description
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study 1. Validation of ECI against conventional methods of assessing tip tissue contact and 2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits: * ECG * Query regarding adverse events since the last visit * Assessment of anti-arrhythmic and anti-coagulation medication * Query regarding recurrence or repeat ablation for typical atrial flutter
Interventions
DEVICETreatment Arm
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 .
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 antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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 intracardiac 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy | 3 months | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 . | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject/family decision post procedure | 2 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 82 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Age, Continuous | 64.82 years STANDARD_DEVIATION 11.97 |
| Region of Enrollment Canada | 10 participants |
| Region of Enrollment United States | 140 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 134 |
| serious Total, serious adverse events | 3 / 134 |
Outcome results
Primary
Primary Efficacy
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Efficacy | 129 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: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure | 3 participants |
Secondary
Secondary Efficacy
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
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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Secondary Efficacy | 110 participants |