Severe Aortic StenosisSAFE-TAVINCT05492383
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
A study testing TAVI in people with Severe Aortic Stenosis, run by Opsens, Inc. at 6 sites in Spain.
Trial summary
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 6 sitesSpain
- Study dates
- 25 Oct 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Álvaro Cunqueiro
Vigo, 36312
About this study
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
- Being tested
- TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVIDevice
Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during surgery
Secondary outcomes (3)
Presence of major complications (safety)
Presence of major complications related to the SAVVY guidewire including guidewire kink hindering or preventing the advancement of the transcatheter valve system, left ventricular perforation and pacing capture translating into major clinical consequences (transcatheter valve malpositioning or embolization).
Measured: during surgery
Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)
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.
Measured: during surgery
Percentage of patient with valve advancement to intended position (mechanical efficacy)
Effective advancement of the THV delivery system over the SavvyWireTM allowing a precise positioning of the valve to the intended deployment position.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start25 Oct 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opsens, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Rodés-Cabau, Dr, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492383
- Sponsor's protocol ID
- PRT-2015-32
- Acronym
- SAFE-TAVI
- Status last verified
- Apr 2023
- First submitted
- 26 Jul 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37902144
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
- ClinicalTrials.gov ID
- NCT05492383
- Acronym / sponsor ID
- SAFE-TAVI / PRT-2015-32
- Conditions
- Severe Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Opsens, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| Patients with severe symptomatic AS undergoing TAVI | Experimental | Device: TAVIPatients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVIPatients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI) | Device | Patients with severe symptomatic AS undergoing TAVI |
Primary outcome
Percentage of patients with effective rapid pacing run
Time frame: during surgery
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.
3 secondary outcomes
Presence of major complications (safety)
Time frame: during surgery
Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)
Time frame: during surgery
Percentage of patient with valve advancement to intended position (mechanical efficacy)
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 37902144Regueiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Rodés-Cabau, Dr principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI in people with Severe Aortic Stenosis, run by Opsens, Inc. at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with effective rapid pacing run (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.