Clinical trial NCT02759237: The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
Official title: The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Symptomatic Aortic Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2016-05-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Safety outcomes: all major adverse events
timeFrame: 30 days post procedure
measure: MACCE
timeFrame: 30 day post procedure
measure: Acute kidney Injury
timeFrame: 30 day post procedure
measure: Cardiac tamponade
timeFrame: 30 days post procedure
measure: Prosthetic valve dysfunction - including moderate or severe aortic regurgitation
timeFrame: 30 days post procedure
measure: Cardiogenic shock
timeFrame: 30 days post procedure
measure: Prosthetic valve endocarditis
timeFrame: 30 days post procedure
measure: Life-threatening, disabling or major bleeding
timeFrame: 30 days post procedure
measure: Major vascular complication
timeFrame: 30 days post procedure
measure: Cardiac perforation
timeFrame: 30 days post procedure
measure: Valve malpositioning
timeFrame: 30 days post procedure
measure: Thrombosis and coronary occlusion
timeFrame: 30 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Eternal Heart Care Centre
state: Rajasthan
Study officials:
References: