Closure Techniques for Transcatheter Aortic Valve Replacement

(TAVI-CLOSE Trial)

Overseen By Bonnie Ostergren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Non-femoral access, Previous femoral repair, others

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

Compensation: Varies

Number of Visits: 1

Duration: Periprocedural

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for closing an artery after a Transcatheter Aortic Valve Replacement (TAVR). It aims to determine if using two ProGlide devices (a suture-mediated closure system) is as safe and effective as using one ProGlide device with an Angioseal (a vascular closure device). Individuals planning to undergo TAVR through the leg artery and able to provide consent may be suitable candidates for this study.

As an unphased study, this trial offers a unique opportunity to contribute to advancements in heart procedure techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these closure techniques are safe for common femoral arteriotomy closure?

Studies have shown that using two ProGlide devices to close large blood vessel openings after heart valve procedures reduces the risk of serious bleeding. This method proves particularly useful for more complex procedures. Research also indicates that combining one ProGlide device with one Angio-Seal device might be even safer and more effective in preventing blood vessel issues. Both methods are well-tolerated, with no major safety concerns reported for either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these closure techniques for Transcatheter Aortic Valve Replacement (TAVR) because they aim to improve how blood vessels are sealed after the procedure. Unlike traditional methods that might use a single closure device, this trial is exploring two innovative combinations: one using dual Perclose Proglide devices and another using a single Perclose Proglide device plus an Angioseal. These approaches could potentially enhance the safety and recovery time for patients by providing more robust and reliable vessel closure, minimizing complications like bleeding. By refining these techniques, researchers hope to make TAVR safer and more efficient for patients.

What evidence suggests that these closure techniques are effective for Transcatheter Aortic Valve Replacement?

In this trial, participants will undergo one of two closure techniques following transcatheter aortic valve replacement. Research has shown that using two Perclose Proglide devices, which participants in one trial arm will receive, reliably closes blood vessel openings after heart valve replacement. Studies indicate this method is simple, effective, and safe, with a strong record of reducing major blood vessel problems. Alternatively, participants in another trial arm will receive one Perclose Proglide device along with an Angioseal device. This combination also appears promising for safety and effectiveness, having significantly reduced major blood vessel complications. Both methods aim to minimize post-procedure issues, but the best choice may depend on individual needs and circumstances. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for a heart valve replacement through the thigh artery and can consent to participate. It's not open to those with past thigh artery issues, non-thigh surgery plans, involvement in conflicting studies, or inability to provide consent.

Inclusion Criteria

I am scheduled for a heart valve replacement through my leg.

Able to provide written informed consent prior to study participation

Exclusion Criteria

I have had a pseudoaneurysm in my thigh artery before.

Non-femoral access

Currently enrolled in another research study that has not granted permission to dual-enroll.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transfemoral Transcatheter Aortic Valve Replacement and receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal

Periprocedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical changes, re-interventions, and peripheral pulse evaluation

4 weeks

1 visit (in-person) at 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Double Perclose Proglide
• Single Perclose Proglide plus Angioseal

Trial Overview The study compares two methods of closing the thigh artery after heart valve replacement: using two ProGlide devices versus one ProGlide plus an Angioseal device. Participants will be randomly assigned to either method in this safety-focused trial.

How Is the Trial Designed?

Group I: Dual Perclose Proglide Active Control 1 Intervention

Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.

Group II: Single Perclose Proglide plus Angioseal Active Control 1 Intervention

Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35420254/

Single versus double Perclose techniques for vascular ... A single Perclose device is a safe means of vascular closure during TF-TAVR and may have important clinical benefits compared to the commonly used two-device ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2025.09.882

TCT-721 Single- vs Double Perclose-Proglide Device ... While double Perclose technique is used in most centers, recent studies indicate that single Perclose technique may be advantageous in terms of ...

3. 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%) ...

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

Single versus double Perclose techniques for vascular ... Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral ...

5. 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 ... Conclusions: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI. Introduction.

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

Large-bore arterial access closure after transcatheter aortic ... The ProGlide showed the highest likelihood to reduce major or life-threatening bleedings, especially with increasing procedural complexity, and the MANTA device ...

7. jscai.org jscai.org/article/S2772-9303(22)00241-1/fulltext

D-52 | Comparison of Outcomes after MANTA or Perclose ... There are limited comparative safety outcomes data following large-bore access closure devices in patients (pts) undergoing transcatheter aortic valve ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016752732100125X

Single versus double use of a suture-based closure device ... The single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06983938?term=AREA%5BInterventionSearch%5D(proglide)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=1

This Study Will Evaluate the Safety and Potential ... This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide ...