Symptomatic Aortic StenosisCoreValveIndiaNCT02759237

The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)

An observational study of Symptomatic Aortic Stenosis, run by Medtronic Cardiovascular at 1 site in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Aortic Stenosis
What is being tested?: CoreValve System Family
Type of treatment: Medical device
How many people: 3 participants
Where: 1 siteIndia
Study dates: Feb 2016to May 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients identified for treatment of symptomatic aortic stenosis (AS), necessitating The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) as part of standard of care, in accordance with the product label indications (Instructions for Use), contraindications, and warnings

Who may be able to join

Patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
Indications and contraindications are provided in the product Instructions for Use.
Subject is scheduled to receive transcatheter aortic valve
Subject is 18 years of age or older
The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the PMS and the Informed consent for both Audio Visual (AV) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements in India

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

India1 site

Eternal Heart Care Centre
Jaipur, Rajasthan, 302020

Other trials in India

About this study

The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of this PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValve System Family

Read the detailed description

The objective of this PMS will be to monitor and gather data on the safety of The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) in the approved intended use.

The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.

Conditions: Symptomatic Aortic Stenosis
Being tested: CoreValve System Family

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoreValve System FamilyDevice
Also called Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family)
Bioprosthesis: Transcatheter Aortic Valve Implant (TAV - Heart Valve) -Different Models/Sizes of CoreValve/CoreValve Evolut R.
Delivery Catheter System: ACCUTRAK \& EnVeo R - Used to facilitate the placement of the bioprosthesis within the annulus.
Loading System: Compression Loading System \& EnVeo R Loading System - Used to load the TAV onto the delivery system

Study groups in NCT02759237
Study group	Role	What they receive
Patient Group		Patients identified for treatment of symptomatic aortic sten Receives: Device: CoreValve System Family

What is being measured

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

Safety outcomes: all major adverse events
This is a surveillance plan designed to collect and report safety outcomes; hence there are no additional clinical endpoints identified. The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.
Measured: 30 days post procedure
MACCE
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 day post procedure
Acute kidney Injury
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 day post procedure
Cardiac tamponade
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Prosthetic valve dysfunction - including moderate or severe aortic regurgitation
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Cardiogenic shock
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Prosthetic valve endocarditis
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Life-threatening, disabling or major bleeding
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Major vascular complication
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Cardiac perforation
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Valve malpositioning
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure
Thrombosis and coronary occlusion
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Measured: 30 days post procedure

Timeline

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

Feb 2016May 2017

First posted3 May 2016 (estimated)
Study startFeb 2016
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe 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: Other
Time perspective: Prospective
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02759237
Sponsor's protocol ID: Version 1.0 17 February 2016
Other IDs: REF/2016/04/011112
Acronym: CoreValveIndia
Status last verified: Jun 2017
First submitted: 29 Apr 2016
Last updated: 14 Jun 2017
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?

See locations

Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)

All Symptomatic Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
ClinicalTrials.gov ID: NCT02759237
Acronym / sponsor ID: CoreValveIndia / Version 1.0 17 February 2016
Conditions: Symptomatic Aortic Stenosis
Study type: Observational
Recruitment status: Terminated
Enrolment: 3 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: Feb 2016 (actual)
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 3 May 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.

Detailed description

The objective of this PMS will be to monitor and gather data on the safety of The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) in the approved intended use.

The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patient Group	–	Device: CoreValve System FamilyPatients identified for treatment of symptomatic aortic sten

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients identified for treatment of symptomatic aortic stenosis (AS), necessitating The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) as part of standard of care, in accordance with the product label indications (Instructions for Use), contraindications, and warnings

Key inclusion criteria (5 listed)

Patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
Indications and contraindications are provided in the product Instructions for Use.
Subject is scheduled to receive transcatheter aortic valve
Subject is 18 years of age or older
The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the PMS and the Informed consent for both Audio Visual (AV) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements in India

Key exclusion criteria (1 listed)

None

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
CoreValve System FamilyAlso: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family)Bioprosthesis: Transcatheter Aortic Valve Implant (TAV - Heart Valve) -Different Models/Sizes of CoreValve/CoreValve Evolut R. Delivery Catheter System: ACCUTRAK \& EnVeo R - Used to facilitate the placement of the bioprosthesis within the annulus. Loading System: Compression Loading System \& EnVeo R Loading System - Used to load the TAV onto the delivery system	Device	Patient Group

Primary outcome

Safety outcomes: all major adverse events
Time frame: 30 days post procedure
This is a surveillance plan designed to collect and report safety outcomes; hence there are no additional clinical endpoints identified. The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.
MACCE
Time frame: 30 day post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Acute kidney Injury
Time frame: 30 day post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Cardiac tamponade
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Prosthetic valve dysfunction - including moderate or severe aortic regurgitation
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Cardiogenic shock
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Prosthetic valve endocarditis
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Life-threatening, disabling or major bleeding
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Major vascular complication
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Cardiac perforation
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Valve malpositioning
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Thrombosis and coronary occlusion
Time frame: 30 days post procedure
Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Individual participant dataSharing planned: No

Related trials for Symptomatic Aortic Stenosis

Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)

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.

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 Symptomatic Aortic Stenosis, run by Medtronic Cardiovascular at 1 site in India.

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 5 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: stopped early, as of the sponsor's last update on 14 Jun 2017. 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 India. 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 was stopped early. 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?

Safety outcomes: all major adverse events (time frame: 30 days post procedure). The study lists 12 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 NCT02759237.

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 14 Jun 2017.