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

• Sponsor: Opsens, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05492383
• Collaborator: (none)
• Enrollment: 120
• Arm: 1
• Anticipated Duration (Months): 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Aortic Stenosis	Device: TAVI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
• Masking: None (Open Label)
• Masking Description: Investigation participant number only
• Primary Purpose: Other
• Official Title: SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: TAVI; Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)

Outcome Measures

Primary Outcome Measures

1. Effective rapid pacing runs translating into a significant systemic pressure drop facilitating an accurate THV deployment [At 72 hours]

   Evaluation will be in the device implant population. Systolic Pa drop <60 mmHg. 180-220 bpm

Secondary Outcome Measures

1. Safety: Absence of major complications related to the SavvyWire™ [At 72 hours]

   No major complications related to guidewire (kink, perforation, serious pacing failure)

2. Successful valve invasive hemodynamic assessment in conjunction with the OptoMonitor 3 (i.e. ventricular pressure and valve gradient), without additional clinical manipulation [During TAVI intervention]

   Ventricular pressure recording with the SavvyWireTM, allowing gradient calculation and display by the OptoMonitor 3, without the need of additional device exchanges through the aortic valve after valve implantation

3. Successful valve advancement and positioning to the intended position [During TAVI intervention]

   Effective advancement of the THV delivery system over the SavvyWireTM allowing a precise positioning of the valve to the intended deployment position

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Opsens, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Opsens, Inc.
• ClinicalTrials.gov Identifier: NCT05492383
• Other Study ID Numbers: PRT-2015-32
• First Posted: Aug 8, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Aug 8, 2022