Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

NCT05093764 | Recruiting FDA Device

• 1 other identifier: 21-109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Complication rate

  In-hospital stroke, device embolization rate, procedure-related major bleeding

  Through hospital discharge, an average of 2.5 days

Secondary Outcomes (2)

• Mortality

  Through hospital discharge, an average of 2.5 days

• MACCE

  Through hospital discharge, an average of 2.5 days

Study Arms (1)

VIV TAVR with BVF using TCEP

OTHER

All subjects will receive the intervention.

Device: VIV TAVR with BVF using TCEP

Interventions

VIV TAVR with BVF using TCEP DEVICE

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.

VIV TAVR with BVF using TCEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Related 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 S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

  PMID: 24678937 RESULT

• 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 Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

• 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 RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

  PMID: 27040324 RESULT

• 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; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 RESULT

• 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 factors and the relationship to subsequent health status. Heart. 2012 Jan;98(1):18-23. doi: 10.1136/heartjnl-2011-300065. Epub 2011 Jul 7.

  PMID: 21737581 RESULT

• 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-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010 Apr 6;55(14):1427-32. doi: 10.1016/j.jacc.2009.12.026. Epub 2010 Feb 24.

  PMID: 20188503 RESULT

• 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-weighted magnetic resonance imaging study. Circulation. 2010 Feb 23;121(7):870-8. doi: 10.1161/CIRCULATIONAHA.109.855866.

  PMID: 20177005 RESULT

• 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):1950-63. doi: 10.1016/j.jacc.2014.07.986. Epub 2014 Oct 27.

  PMID: 25444149 RESULT

• 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, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.

  PMID: 27815101 RESULT

• 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/j.athoracsur.2017.04.007. Epub 2017 Jun 29.

  PMID: 28669505 RESULT

• 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):e005216. doi: 10.1161/CIRCINTERVENTIONS.117.005216.

  PMID: 28698291 RESULT

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Adnan Chhatriwalla, MD

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Erwin, RN

CONTACT

816-932-7996; serwin@saintlukeskc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 26, 2021
• Study Start: March 2, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)