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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-03-03

Brief Summary

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

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Detailed Description

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Conditions

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Severe Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Investigation participant number only

Study Groups

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Patients with severe symptomatic AS undergoing TAVI

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

Group Type EXPERIMENTAL

TAVI

Intervention Type DEVICE

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

Interventions

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TAVI

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No