Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).
The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Perclose ProStyle closure | Experimental | 50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis |
|
| Group manual compression | Active Comparator | 50 patients treated with manual compression and one figure of eight suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deploying vascular closure device versus manual compression | Procedure | patients will be randomized to either group 1 or group 2 in a 1:1 ratio: |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to ambulation | elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| total post procedure time | elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate | 6 hours |
| time to hemostasis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site
| 6 hours |
| time to discharge eligibility | elapsed time between removal of the final closure device or final sheath and when the patient was eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team | 3 days |
| time to discharge | elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution | 3 days |
| time to closure eligibility | elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath | 6 hours |
| Incidence of major adverse events | Incidence of major adverse events within 30 days after the procedure | 30 days |
| Incidence of minor adverse events | Incidence of minor adverse events within 30 days after the procedure | 30 days |
| Time to final hemostasis | Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications | 3 days |
| Klinik für Innere Medizin III |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |
| Klinik für Rhythmologie | Lübeck | Schleswig-Holstein | 23538 | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |