Aortic Valve StenosisNCT05836311
Single Perclose Escalation Technique for Vascular Closure in TAVR
An observational study of Aortic Valve Stenosis and Structural Valve Deterioration, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- What is being tested?
- One Perclose Proglide Suture and Two Perclose Proglide Suture
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jul 2023to 19 Feb 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing transfemoral TAVI implantation in a single center
Who may be able to join
- Patients older than 18 years
- Patients who have undergone Transfemoral TAVI implantation
Who cannot join
- Patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.
Read the detailed description
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.
- Being tested
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Keywords
- Residual Stenosis
- 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.
One Perclose Proglide SutureDevice
One Perclose Proglide Suture
Two Perclose Proglide SutureDevice
One Perclose Proglide Suture
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with one Perclose Proglide | Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture Receives: Device: One Perclose Proglide Suture | |
| Patients treated with two Perclose Proglide Suture | Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture Receives: Device: Two Perclose Proglide Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)
Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)
Measured: 30 days
EFFICACY:Incidence of successful femoral closure
Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy
Measured: 30 days
Secondary outcomes (5)
Cost-effectiveness evaluation
Cost-effectiveness evaluation between two techniques
Measured: 30 days
Incidence of vascular complications (according to VARC3 criteria)
Incidence of vascular complications (according to VARC3 criteria)
Measured: 30 days
Incidence of bleeding (according to VARC3 criteria)
Incidence of bleeding (according to VARC3 criteria)
Measured: 30 days
All-cause Mortality
All-cause Mortality 30 days after procedure
Measured: 30 days
All-cause Mortality
All-cause Mortality 1 year after procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start19 Jul 2023 (estimated)
- Primary completion19 Feb 2025 (estimated)
- Study completion19 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836311
- Sponsor's protocol ID
- CLOSURE TAVI 1 VERSUS 2
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kodama A, Yamamoto M, Shimura T, Kagase A, Koyama Y, Tada N, Takagi K, Araki M, Yamanaka F, Shirai S, Watanabe Y, Hayashida K. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):E55-E62. doi: 10.1002/ccd.26686. Epub 2016 Oct 27.
PubMed 27785881Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12.
PubMed 31713996
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Perclose Escalation Technique for Vascular Closure in TAVR
- ClinicalTrials.gov ID
- NCT05836311
- Acronym / sponsor ID
- CLOSURE TAVI 1 VERSUS 2
- Keywords
- Residual Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 19 Jul 2023 (estimated)
- Primary completion
- 19 Feb 2025 (estimated)
- Study completion
- 19 Feb 2025 (estimated)
- First posted
- 1 May 2023 (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.
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.
Detailed description
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with one Perclose Proglide | – | Device: One Perclose Proglide SuturePatients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture |
| Patients treated with two Perclose Proglide Suture | – | Device: Two Perclose Proglide SuturePatients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing transfemoral TAVI implantation in a single center
Key inclusion criteria (2 listed)
- Patients older than 18 years
- Patients who have undergone Transfemoral TAVI implantation
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria
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 |
|---|---|---|
| One Perclose Proglide SutureOne Perclose Proglide Suture | Device | Patients treated with one Perclose Proglide |
| Two Perclose Proglide SutureOne Perclose Proglide Suture | Device | Patients treated with two Perclose Proglide Suture |
Primary outcome
SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)
Time frame: 30 days
Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)
EFFICACY:Incidence of successful femoral closure
Time frame: 30 days
Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy
5 secondary outcomes
Cost-effectiveness evaluation
Time frame: 30 days
Incidence of vascular complications (according to VARC3 criteria)
Time frame: 30 days
Incidence of bleeding (according to VARC3 criteria)
Time frame: 30 days
All-cause Mortality
Time frame: 30 days
All-cause Mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 27785881Kodama A, Yamamoto M, Shimura T, Kagase A, Koyama Y, Tada N, Takagi K, Araki M, Yamanaka F, Shirai S, Watanabe Y, Hayashida K. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):E55-E62. doi: 10.1002/ccd.26686. Epub 2016 Oct 27.
- Background: PubMed 31713996Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Structural Valve Deterioration, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VICENTE SERRA GARCIA, MD, PhD (0034932746155, vctsrr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT05836311, which also lists 2 linked publications.
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 3 May 2023.