Aortic StenosisNCT02695147

Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK

An observational study of Aortic Stenosis, run by Royal Sussex County Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016 Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Stenosis
What is being tested?: TAVI
Type of treatment: Surgery or procedure
How many people: 400 participants
Where: No sites listed yet
Study dates: Feb 2016to Jun 2016
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: All patients who received TAVI via the subclavian or direct aortic approach in the UK

Who may be able to join

Recieve TAVI via subclavian or direct aortic apporach in the UK

Who cannot join

About this study

A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016

Conditions: 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.

TAVIProcedure or surgery

Study groups in NCT02695147
Study group	Role	What they receive
TAVI via Subclavian approach		Any TAVI procedure using any valve type performed via the subclavian approach Receives: Procedure: TAVI
TAVI via Direct Aortic approach		Any TAVI procedure using any valve type performed via the direct aortic approach Receives: Procedure: TAVI

What is being measured

The primary outcome is the main question the study is designed to answer.

MACE
Measured: Up to 5 years (average 3 years)

Secondary outcomes (1)

Procedural Complications
Measured: 30 dyas post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Jun 2016

First posted1 Mar 2016 (estimated)
Study startFeb 2016
Primary completionJun 2016 (estimated)
Study completionJun 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02695147
Sponsor's protocol ID: RoyalSussexTAVISCvsDA
Status last verified: Feb 2016
First submitted: 24 Feb 2016
Last updated: 1 Mar 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK
ClinicalTrials.gov ID: NCT02695147
Acronym / sponsor ID: RoyalSussexTAVISCvsDA
Conditions: Aortic Stenosis
Study type: Observational
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Royal Sussex County HospitalUniversity, hospital or other
Collaborators: National Institute for Cardiovascular Outcomes Research
Study start: Feb 2016
Primary completion: Jun 2016 (estimated)
Study completion: Jun 2016 (estimated)
First posted: 1 Mar 2016 (estimated)
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.

A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
TAVI via Subclavian approach	–	Procedure: TAVIAny TAVI procedure using any valve type performed via the subclavian approach
TAVI via Direct Aortic approach	–	Procedure: TAVIAny TAVI procedure using any valve type performed via the direct aortic approach

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients who received TAVI via the subclavian or direct aortic approach in the UK

Key inclusion criteria (1 listed)

Recieve TAVI via subclavian or direct aortic apporach in the UK

Key exclusion criteria (1 listed)

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
TAVI	Procedure or surgery	TAVI via Direct Aortic approach, TAVI via Subclavian approach

Primary outcome

MACE
Time frame: Up to 5 years (average 3 years)

1 secondary outcome

Procedural Complications
Time frame: 30 dyas post procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by Royal Sussex County Hospital.

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 1 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

MACE (time frame: Up to 5 years (average 3 years)). 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 NCT02695147.

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 1 Mar 2016.