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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of using one Perclose device (a vascular closure device) versus two devices for closing blood vessels during TAVR, a heart procedure that replaces a valve. The researchers aim to determine which method stops bleeding faster and results in fewer complications. This trial may suit individuals undergoing TAVR through the groin (transfemoral) who have not experienced recent blood vessel issues or certain heart conditions. As an unphased study, this trial provides a unique opportunity to contribute to medical research and potentially improve outcomes for future TAVR patients.

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 prior data suggests that these Perclose devices are safe for TAVR?

Research has shown that using Perclose devices to close arteries after TAVR (a heart procedure) is generally safe. Studies examining the dual Perclose method for closing large arteries, such as those in TAVR, found it effective in reducing major complications. However, a small risk of bleeding or device failure remains, with one study noting bleeding in 11.6% of cases.

Research suggests that the single Perclose device is also a safe option. It may offer similar benefits with fewer devices, potentially lowering some risks. One study found the single device to be safe and possibly advantageous over using two devices.

Both methods aim to stop bleeding after TAVR, but the single device might be a simpler choice. Overall, these treatments are well-tolerated, though some risks remain, as with any medical procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative approaches to vascular closure during Transcatheter Aortic Valve Replacement (TAVR) procedures. Unlike traditional closure methods, which may rely on sutures or manual pressure alone, these methods use the Perclose vascular closure device to enhance hemostasis. The dual Perclose approach involves using two devices for added security, potentially reducing bleeding complications compared to single-device or manual methods. Meanwhile, the single Perclose device approach offers a streamlined alternative, potentially simplifying the procedure and reducing device use without compromising safety. Both approaches aim to improve patient outcomes by minimizing procedure-related complications and enhancing recovery.

What evidence suggests that using one Perclose device is effective for TAVR?

This trial will compare the use of one versus two Perclose devices for closing blood vessels during TAVR, a heart valve procedure. Research has shown that using a single Perclose device can be safe and may effectively close the entry point, reducing the need for additional devices. Meanwhile, using two Perclose devices also works well, particularly in lowering the risk of complications like tearing of the artery wall. Both methods aim to stop bleeding and aid in patient recovery. The choice between one or two devices in this trial will depend on each patient's specific needs. ^{1 2 5 6 7}

Who Is on the Research Team?

Suhail Q Allaqaband, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Single Device Experimental Treatment 1 Intervention

A single Perclose device will be used for pre-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 pre-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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509625005047

Comparative Effectiveness of Vascular Closure Device ... SUCRA rankings indicated FemoSeal-ProGlide demonstrated best efficacy in reducing major vascular complications (89.7%), 30-day mortality (94.5%) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472788/

Large-bore arterial access closure after transcatheter aortic ... We aimed to evaluate the impact of different large-bore arterial access closure devices on clinical outcomes after TAVR.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/ccd.30176

Single versus double Perclose techniques for vascular ... There was also a significant improvement in arterial dissection rates (0.6% vs. 4.6%, p = 0.004), stenosis >50% (1.3% vs. 4.4%, p = 0.028), and ...

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/dual-proglide-versus-proglide-and-femoseal-for-vascular-access-haemostasis-after-transcatheter-aortic-valve-implantation

Dual ProGlide versus ProGlide and FemoSeal for vascular ... This study compared outcomes of 874 patients who received either two ProGlide devices or one ProGlide plus one FemoSeal for vascular closure after ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0828282X24009371

Dual ProGlide vs ProGlide and Angio-Seal for Femoral ... Combined PP+AS for large-bore femoral access hemostasis after TAVR promises to be more effective and safer than dual PP in terms of vascular complications.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06871774?term=AREA%5BConditionSearch%5D(Transcatheter%20aortic%20valve%20replacement)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=2

Comparison of Single vs. Dual Perclose Devices for Large- ... This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR) ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057856

The CHOICE-CLOSURE Randomized Clinical Trial Access site– or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91–2.73], P=0.133) and device failure in ...