Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

Aortic Valve Disease Clinical Trial

Official title:

Quantification of Debris Captured Using Transcatheter Cerebral Embolic Protection (TCEP) During Valve in Valve Transcatheter Aortic Valve Replacement (VIV TAVR) With Bioprosthetic Valvular Fracture (BVF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093764
• Other study ID #: 21-109
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Saint Luke's Health System
• Contact: Sheila Erwin, RN
• Phone: 816-932-7996
• Email: serwin[@]saintlukeskc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF)

Description:

SENTINEL VIV-TAVR is a prospective, single-center, single-arm, unblinded pilot trial. A total of 20 subjects with severe symptomatic bioprosthetic aortic valve degeneration, who are deemed to be at high or prohibitive mortality risk related to surgical aortic valve replacement, and are undergoing VIV-TAVR and BVF, will be enrolled at the Mid-America Heart Institute, St-Luke's Hospital of Kansas City. Subjects will initially have an aortic arch angiogram done to confirm appropriate anatomy, followed by the SENTINEL device implanted through right radial artery approach. After that, patients will undergo VIV TAVR, using a commercially available transcatheter heart valve, followed by bioprosthetic valve fracture (BVF) as indicated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and Women = 18 years of age

• The patient has severe bioprosthetic aortic valve degeneration (stenosis, insufficiency, or mixed valve disease) and a clinical indication for VIV TAVR

• The bioprosthetic valve can be fractured with high pressure balloon inflation.

• The patient is deemed at prohibitive or high mortality risk related to surgical aortic valve replacement as assessed by the Heart Team

• For procedural planning, all patients must have a CT angiogram of the chest, abdomen and pelvis to confirm:

A. Adequate femoral access for the TAVR procedure B. Appropriate right subclavian, carotid and brachiocephalic as well as left carotid artery anatomy for the SENTINEL device deployment.

• The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial

• The patient is able and willing to return for required follow-up visits and examinations

• The patient is evaluated by the multidisciplinary heart-valve team and found to be a suitable for the procedure.

Exclusion Criteria:

• Patients with low or moderate mortality risk from surgical aortic valve replacement

• Patients with bioprosthetic valves that cannot be fractured with standard non-compliant valvuloplasty balloons (Table 1)

• Patients with evidence of significant carotid artery stenosis (i.e., carotid stenosis = 50%), noted on ultrasound duplex imaging or CT angiography.

• Patients with evidence of right subclavian/brachiocephalic artery stenosis

• Patients with right arm/forearm dialysis fistula or graft.

• Patients with harvested right radial artery for a previous coronary bypass surgery.

• Patients with prohibitive aortic arch anomalies for SENTINEL device implantation.

• The patient with history of cerebrovascular event (CVA) within within 6 months.

• Patient with incidental left atrial appendage thrombus noted on TEE or CT imaging.

• The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable)

• The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child-bearing potential

• Any clinically significant medical condition or presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or SENTINEL

• The patient has a life expectancy of less than one year

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• VIV TAVR with BVF using TCEP
The insertion and retrieval of the SENTINEL device is performed at the time of the patients TAVR procedure in the same setting while they are sedated under moderate sedation or general anesthesia depending on the case. The device is inserted at the initiation of the procedure through 6F right radial artery access and the filters are positioned in the left common carotid artery and brachiocephalic artery. After deployment, the usual TAVR procedure is performed. At the conclusion of the procedure, the SENTINEL device is extracted and hemostasis is achieved at the radial access site in the usual fashion with patent hemostasis.

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (11)

Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth — View Citation

Allen KB, Chhatriwalla AK, Cohen DJ, Saxon JT, Aggarwal S, Hart A, Baron S, Davis JR, Pak AF, Dvir D, Borkon AM. Bioprosthetic Valve Fracture to Facilitate Transcatheter Valve-in-Valve Implantation. Ann Thorac Surg. 2017 Nov;104(5):1501-1508. doi: 10.1016 — View Citation

Chhatriwalla AK, Allen KB, Saxon JT, Cohen DJ, Aggarwal S, Hart AJ, Baron SJ, Dvir D, Borkon AM. Bioprosthetic Valve Fracture Improves the Hemodynamic Results of Valve-in-Valve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jul;10(7) — View Citation

Fairbairn TA, Mather AN, Bijsterveld P, Worthy G, Currie S, Goddard AJ, Blackman DJ, Plein S, Greenwood JP. Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk fact — View Citation

Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion- — View Citation

Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-we — View Citation

Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svens — View Citation

Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Inves — View Citation

Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson — View Citation

Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTN — View Citation

Spaziano M, Francese DP, Leon MB, Genereux P. Imaging and functional testing to assess clinical and subclinical neurological events after transcatheter or surgical aortic valve replacement: a comprehensive review. J Am Coll Cardiol. 2014 Nov 4;64(18):1950 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of debris	Amount of debris captured by the SENTINEL TCEP device in VIV TAVR with BVF patients compared to historical data	During surgical procedure
Primary	Complication rate	In-hospital stroke, device embolization rate, procedure-related major bleeding	Through hospital discharge, an average of 2.5 days
Secondary	Mortality	Deaths from all causes	Through hospital discharge, an average of 2.5 days
Secondary	MACCE	Major adverse cardiac and cerebrovascular events	Through hospital discharge, an average of 2.5 days