Single Perclose Escalation Technique for Vascular Closure in TAVR

Study Overview
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Brief Summary
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This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

Detailed Description
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Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double preclose approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.

Official Title
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Single Perclose Escalation Technique for Vascular Closure in TAVR

Conditions
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Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration

Intervention / Treatment
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* Device: One Perclose Proglide Suture
* Device: Two Perclose Proglide Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients who have undergone Transfemoral TAVI implantation Exclusion Criteria: Patients who do not meet the inclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with one Perclose Proglide<br>Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture | Device: One Perclose Proglide Suture<br>* One Perclose Proglide Suture<br>|
| Patients treated with two Perclose Proglide Suture<br>Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture | Device: Two Perclose Proglide Suture<br>* One Perclose Proglide Suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) | Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) | 30 days | 
| EFFICACY:Incidence of successful femoral closure | Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness evaluation | Cost-effectiveness evaluation between two techniques | 30 days | 
| Incidence of vascular complications (according to VARC3 criteria) | Incidence of vascular complications (according to VARC3 criteria) | 30 days | 
| Incidence of bleeding (according to VARC3 criteria) | Incidence of bleeding (according to VARC3 criteria) | 30 days | 
| All-cause Mortality | All-cause Mortality 30 days after procedure | 30 days | 
| All-cause Mortality | All-cause Mortality 1 year after procedure | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Residual Stenosis