Typical Atrial Flutter
Conditions
Keywords
cavo-tricuspid dependent
Brief summary
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).
Detailed description
This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
Interventions
DEVICETherapy Cool Path Duo
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
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 (cavotricuspid isthmus dependent) * If subjects are receiving antiarrhythmic 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 * Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant) * Evidence of intracardiac thrombus or a history of clotting disorders * Participation in another investigational study * Cardiac surgery within 1 month of the intended procedure date * Allergy or contraindication to Heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. | 7 days |
| Primary Efficacy- 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 Cool Path Duo Ablation Catheter System is Obtained. | 30 mins |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure | 3 months |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm | 188 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 111 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants |
| Age, Continuous | 66.47 years STANDARD_DEVIATION 11.16 |
| Region of Enrollment Canada | 26 participants |
| Region of Enrollment United States | 162 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 188 |
| serious Total, serious adverse events | 12 / 188 |
Outcome results
Primary
Primary Efficacy- 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 Cool Path Duo Ablation Catheter System is Obtained.
Time frame: 30 mins
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Efficacy- 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 Cool Path Duo Ablation Catheter System is Obtained. | 181 participants |
Primary
Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. | 12 participants |
Secondary
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure | 173 participants |