SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

NCT05492383 | Completed DMC

• 1 other identifier: PRT-2015-32
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with effective rapid pacing run

  Effective rapid pacing will be defined as an adequate ventricular pacing capture by the SavvyWireTM leading to a reduction of systolic aortic pressure value \<60 mmHg.

  during surgery

Secondary Outcomes (3)

• Presence of major complications (safety)

  during surgery

• Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)

  during surgery

• Percentage of patient with valve advancement to intended position (mechanical efficacy)

  during surgery

Study Arms (1)

Patients with severe symptomatic AS undergoing TAVI

EXPERIMENTAL

Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation

Device: TAVI

Interventions

TAVI DEVICE

Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)

Patients with severe symptomatic AS undergoing TAVI

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years old
• Subject has a severe symptomatic AS undergoing a TAVI procedure
• Subject with a THV for which rapid pacing is considered necessary during valve implantation
• Subject agrees to participate in the study and is able to sign the informed consent form

You may not qualify if:

• Failure to provide signed informed consent
• Extremely horizontal aorta (aortic root angle ≥70°)
• Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
• Inability to receive full anticoagulation during the TAVI procedure
• Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.

Sponsors & Collaborators

• Opsens, Inc.: lead

Study Sites (6)

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, 36312, Spain

Location

Related Publications (1)

• Regueiro A, Alperi A, Vilalta V, Asmarats L, Baz JA, Nombela-Franco L, Calabuig A, Munoz-Garcia A, Sabate M, Moris C, Picard-Deland M, Pelletier-Beaumont E, Rodes-Cabau J. Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):3016-3023. doi: 10.1016/j.jcin.2023.10.035. Epub 2023 Oct 23.

  PMID: 37902144 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Josep Rodés-Cabau, Dr

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigation participant number only
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 8, 2022
• Study Start: October 25, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)