Closure Technique, Transcatheter Aortic Valve Replacement
Conditions
Keywords
Transcatheter aortic valve replacement, Perclose Proglide, Angioseal
Brief summary
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.
Detailed description
This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study. Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure. The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.
Interventions
DEVICEDouble Perclose Proglide
Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
DEVICESingle Perclose Proglide plus Angioseal
Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Planned to undergo transcatheter aortic valve replacement via femoral access * Able to provide written informed consent prior to study participation
Exclusion criteria
* Non-femoral access * Previous repair or intervention of the common femoral artery * Previous pseudoaneurysm of the common femoral artery * Children below 18 years, prisoners, and patients who are unable to provide consent are excluded. * In another research study that has not granted permission to dual-enroll.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Access-related Bleeding and Vascular Complications | Periprocedural through hospital discharge, an average of 1.5 days | Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Complications | Periprocedural through hospital discharge, an average of 1.5 days | A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection. |
| Procedural Total Duration | Periprocedural, around 1.5 hours | Total procedure duration from procedure start to completion. |
| Fluoroscopy Time | Periprocedural, around 1.5 hours | Total fluoroscopy time will be measured from procedure start to completion. |
| Contrast Volume | Periprocedural, about 1.5 hours | Total contrast volume will be measured from the start of the procedure until completion. |
| Length of Hospital Stay | From patient arrival until discharge, about 1.5 days | The length of the hospital stay will be collected. |
| Cost of Hospital Stay | Patient arrival to discharge, about 1.5 days | The cost of the hospital stay will be collected. |
| Minor Vascular Complications | Periprocedural, about 1.5 hours | The number of participants with minor vascular complications will be collected |
| Need for Secondary Closure Device | Periprocedural, about 1.5 hours | The number of participants with the need for a secondary closure device will be collected. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 85 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 80.0 years STANDARD_DEVIATION 7.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 4 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 47 | 0 / 42 |
| other Total, other adverse events | 2 / 47 | 0 / 42 |
| serious Total, serious adverse events | 1 / 47 | 0 / 42 |
Outcome results
None listed