A Phase 4 interventional study of RF energy delivery for treatment of Typical Atrial flutter in Atrial Flutter, sponsored by Biosense Webster, Inc.. Completed at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-05.
Sponsored by Biosense Webster, Inc. · Phase 4, Interventional, and Treatment
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).
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.
213 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.
This study's enrollment of 291 is above the median of 134 across 145 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Also known as: Therapeutic Catheters
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
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
First subject enrollment on June 7, 2006 Last subject enrolled August 14, 2007. Enrollment rate was 20.5 subjects per month across 21 hospitals
| Milestone | Ablation Group |
|---|---|
| Started | 291 |
| Completed | 267 |
| Not completed | 24 |
| Withdrew: Excluded per protocol | 24 |
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.
| percentage of participants | Ablation Group |
|---|---|
| Percentage of Subjects With Complete Bidirectional Conduction Block. | 93.3 (90.1 to 100) |
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 participants | Ablation Group |
|---|---|
| Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. | 1.5 (0 to 3.4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ablation Group | — | 4/267 (1.5%) | 73/267 (27.3%) |
| Event | Ablation Group |
|---|---|
| Complete Heart BlockCardiac disorders | 2/267 |
| Pulmonary EmbolusRespiratory, thoracic and mediastinal disorders | 1/267 |
| Acute myocardial infarctionCardiac disorders | 1/267 |
| Event | Ablation Group |
|---|---|
| Adverse Events Greater than 7 Days- Unrelated to Device or ProcedureGeneral disorders | 28/267 |
| Adverse Events within 7 Days- Unrelated to Device or ProcedureGeneral disorders | 24/267 |
| Adverse Events within 7 Days- Procedure RelatedGeneral disorders | 18/267 |
| Adverse Events within 7 Days- Possibly Procedure RelatedGeneral disorders | 12/267 |
| Adverse Events Greater than 7 Days- Procedure RelatedGeneral disorders | 2/267 |
| Adverse Events within 7 Days- Device RelatedGeneral disorders | 1/267 |
| Adverse Events within 7 Days- Possibly Device RelatedGeneral disorders | 0/267 |
| Adverse Events Greater than 7 Days- Device RelatedGeneral disorders | 0/267 |
| Adverse Events Greater than 7 Days- Possibly Device RelatedGeneral disorders | 0/267 |
| Adverse Events Greater than 7 Days- Possibly Procedure RelatedGeneral disorders | 0/267 |
| Age, Categorical(Participants) | Ablation Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 136 |
| >=65 years | 155 |
| Age Continuous(years) | Ablation Group |
|---|---|
| Mean | 65.2 ± 12.1 |
| Sex: Female, Male(Participants) | Ablation Group |
|---|---|
| Female | 48 |
| Male | 243 |
| Region of Enrollment(participants) | Ablation Group |
|---|---|
| United States | 291 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Biosense Webster, Inc.