Atrial Flutter
Conditions
Keywords
Heart Disease, Atrial Flutter, Typical Atrial Flutter
Brief summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Detailed description
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
Interventions
DEVICERF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Sponsors
Biosense Webster, Inc.
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
* Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation. * At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment. * 18 years of age or older * Informed consent
Exclusion criteria
* Intracardiac thrombus * Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure * Women who are pregnant * Cardiac surgery (ventriculotomy or atriotomy) within the past two months * Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement * Unstable angina or acute myocardial infarction within 3 months * Awaiting cardiac transplantation * Heart disease in which corrective surgery is anticipated within 6 months * Presence of condition that precludes appropriate vascular access * Enrolled in any investigational device exemption (IDE) investigating study for a device or drug * High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician) * Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. | 7 Days | The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death. |
| Percentage of Subjects With Complete Bidirectional Conduction Block. | During the procedure | Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure. |
Countries
United States
Participant flow
Recruitment details
First subject enrollment on June 7, 2006 Last subject enrolled August 14, 2007. Enrollment rate was 20.5 subjects per month across 21 hospitals
Participants by arm
| Arm | Count |
|---|---|
| Ablation Group Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter. | 291 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded per protocol | 24 |
Baseline characteristics
| Characteristic | Ablation Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 155 Participants |
| Age, Categorical Between 18 and 65 years | 136 Participants |
| Age Continuous | 65.2 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 291 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 243 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 267 |
| serious Total, serious adverse events | 4 / 267 |
Outcome results
Primary
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
Time frame: 7 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ablation Group | Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. | 1.5 percentage of participants |
Comparison: The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%p-value: 0.05Exact Binomial Distribution
Primary
Percentage of Subjects With Complete Bidirectional Conduction Block.
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Time frame: During the procedure
Population: Per protocol analysis. Number differs from Participant Flow because only 253 subjects were considered for the efficacy cohort.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ablation Group | Percentage of Subjects With Complete Bidirectional Conduction Block. | 93.3 percentage of participants |
Comparison: An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.p-value: 0.05Exact binomial distribution