Arrhythmia
Conditions
Keywords
ABT-CIP-10410, Ablation, DUS, Femoral DUS
Brief summary
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.
Interventions
DEVICEPerclose ProGlide SMC System and/or Perclose ProStyle SMCR System
The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein * All the access sites are planned to be treated with Perclose SMC * Written informed consent is obtained prior to the procedure
Exclusion criteria
* Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure * Prior ipsilateral deep vein thrombosis within 6 months * International Normalization Ratio \>3.5 for patients on warfarin * Subject who is not able to ambulate pre-procedure * Women who are pregnant (based on site standard pre-procedure pregnancy test) * Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Within 24 hours of procedure. | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization. |
| Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Within 24 hours of procedure. | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications. |
Countries
United States
Participant flow
Recruitment details
A total of 36 subjects will be registered at 2 US investigational sites. All subjects must have femoral duplex ultrasound (DUS) at discharge and at a 30-dayfollow-up visit (if any access site-related vascular complications(either symptomatic/visible or asymptomatic/nonvisible), nerve injury, or infection at discharge, by either the investigator or the core laboratory).
Participants by arm
| Arm | Count |
|---|---|
| All Registered Patients All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System.
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | All Registered Patients |
|---|---|
| Age, Continuous | 62.9 Years STANDARD_DEVIATION 10.7 |
| Arrhythmia Atrial Flutter | 6 Participants |
| Arrhythmia Other | 2 Participants |
| Arrhythmia Paroxysmal AF | 17 Participants |
| Arrhythmia Persistent AF | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 5 / 36 |
| serious Total, serious adverse events | 1 / 36 |
Outcome results
Primary
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.
Time frame: Within 24 hours of procedure.
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Femoral Vein Stenosis (> 50%) Development at the Puncture | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Deep Vein Thrombosis in the Target Limb | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Hematoma | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Pseudoaneurysm | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Requiring Surgical or Percutaneous Repair | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Requiring Thrombin Injection, Fibrin Adhesive Injection, or Ultrasound-guided Compression | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Arteriovenous (AV) Fistula | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Venous Tear | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Venous Perforation | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Arterial Tear | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Arterial Perforation | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Other Vascular Complication | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Arterial Stenosis | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Arterial Dissection | 0 Participants |
| All Registered Patients | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Mobile Perclose Common Femoral Vein | 0 Participants |
Primary
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.
Time frame: Within 24 hours of procedure.
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Femoral Vein Stenosis (> 50%) Development at the Puncture Site related to Closure Techniqu | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Deep Vein Thrombosis in the Target Limb | 3 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Hematoma | 1 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Pseudoaneurysm | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Arteriovenous (AV) Fistula | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Venous Tear | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Venous Perforation | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Arterial Tear | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Arterial Perforation | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Other Vascular Complication | 1 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Arterial Stenosis | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Arterial Dissection | 0 Participants |
| All Registered Patients | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Mobile Perclose Common Femoral Vein | 1 Participants |