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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P110016 S080/ PAS001 |
| Date Original Protocol Accepted |
12/14/2022
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| Date Current Protocol Accepted |
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| Study Name |
LESS VT Continued F/u of IDE
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| Device Name |
FlexAbility™ Ablation Catheter, Sensor Enabled™
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study objective is to characterize the safety and effectiveness of the FlexAbility, SE Ablation Catheter for the treatment of monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease through 12 months post-procedure. This study should be conducted per version H of the LESS VT protocol. The study will consist of all IDE patients who are currently enrolled and alive and will evaluate the protocol specified descriptive 12-month endpoints.
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| Study Population |
The primary analysis population for the primary safety endpoint analysis will include subjects enrolled in the NICM cohort who have the catheter inserted in the EP lab for the VT ablation procedure (regardless of whether or not RF energy is delivered) and have crossed the 7-day post index ablation time point.
Subjects who have an ablation procedure with an ablation catheter other than the FlexAbility SE catheter (regardless of whether or not RF energy is delivered) will have primary safety events that occur during or after the ablation with another catheter excluded from this analysis.
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| Sample Size |
The sample sizes required for evaluation of the primary safety and effectiveness endpoints in the NICM cohort are 171 and 173 subjects, respectively. The primary effectiveness endpoint requires a larger sample size (N=173), and therefore determines the sample size for the subjects who have the catheter inserted in the EP lab in the NICM cohort. To account for 5% of subjects who may enroll but not have had the study catheter inserted in the EP lab, 182 NICM subjects may enroll in this trial.
This follow up study will consist of all IDE patients who are currently enrolled and alive and will evaluate the protocol specified descriptive 12-month endpoints.
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| Key Study Endpoints |
The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure as adjudicated by CEC.
The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose of Class I or III AAD at 6 months following the index ablation procedure, where sustained MMVT is defined as a continuous MMVT for >30 seconds, or MMVT requiring intervention for termination regardless of its duration. MMVT will be adjudicated by the ICD Event Review Committee.
Descriptive endpoints
1. Changes in SF-12 Quality of Life physical and mental component score at 6 and 12 months follow-up post index procedure from baseline
2. Changes in HADS score at 6 and 12 months follow-up post index procedure from baseline
3. Freedom from appropriate ICD shocks at 6 months (183 days) post index procedure, adjudicated by the ICD Event Review Committee
4. Freedom from recurrent sustained MMVT and a new or increased dose of Class I or III AAD at 12 months
5. Spontaneous recurrence of any sustained VT during the follow-up periods of 6 months and 12 months
6. Freedom from VT in the absence of Class I and III AAD at 12 months
7. 12-month mortality
8. Number of VT recurrences during the follow-up periods of 6 months and 12 months (VT recurrence is defined as any episode of VT greater than 30s duration or that requires ICD intervention).
9. Proportion of procedures in which the acute procedural endpoint (as defined in Appendix D) was achieved
10. Procedure time
11. Fluoroscopic time
12. Rate of cardiovascular-related and procedure-related major complications through 30 days post index ablation procedure.
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| Follow-up Visits and Length of Follow-up |
The total duration of the clinical investigation is expected to be approximately 3.5 years.
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