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New treatment option for Transcatheter Aortic Valve Implantation (TAVI)
Official title Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
ClinicalTrials.gov ID: NCT06962371
What this study is testing
- What it's testing
- The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is ≥18 years of age;
- The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
- The patient is willing to comply with protocol-specified follow-up evaluations;
- The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the...
You likely can't join if
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or treatment procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders.
- Patients who are pregnant, as confirmed by a positive pregnancy test. General Exclusion Criteria
See the full eligibility criteria
- The patient is ≥18 years of age;
- The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
- The patient is willing to comply with protocol-specified follow-up evaluations;
- The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or treatment procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders.
- Patients who are pregnant, as confirmed by a positive pregnancy test. General Exclusion Criteria
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or treatment procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders. 5\. Patients who are pregnant, as confirmed by a positive pregnancy test. Magnetic resonance imaging exclusion criteria:
- Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
- Contraindications to MRI (people with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
- High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., people with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
- Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
- Claustrophobia precluding MRI scanning.
The study team makes the final eligibility decision.
Where it's taking place
- Clayton, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clayton, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.