Perclose Devices for TAVR

Overseen By Suhail Q Allaqaband, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Low molecular weight heparin

Disqualifiers: Alternative access routes, Severe morbidity, Mobility issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the use of one Perclose device to the usual approach of two devices during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using low molecular weight heparin (a type of blood thinner), you should not take it within 8 hours before or after the procedure.

What data supports the effectiveness of the Perclose Devices treatment for TAVR?

The Perclose ProGlide device is widely used and considered a safe and effective method for closing large blood vessel access sites during procedures like TAVR. Studies have shown that using either one or two devices can effectively close the access site, with some evidence suggesting that a single device may reduce complications and costs. ^{1 2 3 4 5}

Is the Perclose ProGlide device safe for use in humans?

The Perclose ProGlide device is considered safe for closing blood vessel access sites in procedures like transcatheter aortic valve replacement (TAVR). Studies have shown it reduces complications like bleeding compared to other methods, and it is widely used in clinical practice. ^{1 2 3 6 7}

How does the Perclose device treatment for TAVR differ from other treatments?

The Perclose device treatment for TAVR is unique because it uses a suture-mediated closure system to close the vascular access site, which can be done with either a single or double device approach. This method is different from traditional manual compression or surgical cut-down techniques, potentially reducing complications, complexity, and cost. ^{1 2 3 4 5}

Research Team

Suhail Q Allaqaband, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for patients undergoing a heart valve replacement procedure called TAVR. Participants should be suitable candidates for the procedure and specifically require large-bore access closure, which is part of the process.

Inclusion Criteria

* Patient age 18 or older

* Transfemoral transcatheter aortic valve replacement (TAVR)

* Implantation of CoreValve replacement valve

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TAVR) with either single or dual Perclose devices for vascular access closure

1 day

1 visit (in-person)

Immediate Post-procedure Monitoring

Participants are monitored for life-threatening bleeding and time to hemostasis within 24 hours post-procedure

24 hours

In-Hospital Monitoring

Participants are monitored for vascular complications and limb ischemia during the index hospitalization

5 days

Follow-up

Participants are monitored for limb ischemia related to TAVR within 30 days post-procedure

30 days

Treatment Details

Interventions

• Dual Perclose vascular closure device
• Single Perclose Pro vascular closure device

Trial Overview The study tests if using one Perclose Pro vascular closure device is as effective as using two such devices in stopping bleeding after TAVR. It compares time to hemostasis (bleeding stop) and rates of complications between the single-device and dual-device methods.

Participant Groups

Group I: Single Device Experimental Treatment 1 Intervention

A single Perclose device will be used for initial closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.

Group II: Two device Active Control 1 Intervention

Two Perclose devices will be used for initial closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

The Perclose ProGlide™ system is a safe and effective vascular closure device that has been shown to reduce complications associated with vascular access procedures compared to traditional methods like manual compression and surgical cut-down.

Studies indicate that using the Perclose ProGlide™ system can lead to quicker recovery times, including reduced time to deambulation and discharge, as well as decreased patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perclose Proglide™ for vascular closure. Del Prete, A., Della Rocca, DG., Calcagno, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single versus double Perclose techniques for vascular closure during transfemoral transcatheter aortic valve replacement. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Perclose Proglide™ for vascular closure. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A single stich is maybe enough. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. [2013]