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Trial record 2 of 1477 for:    PARTNER trial

The PARTNER TRIAL - Post Approval Study Part II (PAS II)

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ClinicalTrials.gov Identifier: NCT02184442
Recruitment Status : Active, not recruiting
First Posted : July 9, 2014
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
American College of Cardiology
Society of Thoracic Surgeons (STS)
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of this post approval study is to determine the safety, effectiveness and learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable patients with Severe Symptomatic Native Aortic Stenosis via all access sites.

Condition or disease Intervention/treatment Phase
Severe Symptomatic Calcific Aortic Stenosis Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Phase 4

Detailed Description:
The following concerns will be addressed in this trial: 1) long term (5 year) valve implant durability with echocardiography, 2) long-term (5 year) quality of life assessment with KCCQ-12 instrument, 3) assessment of learning curve in the post approval setting (utilizing the VARC composite for procedural success as a benchmark), 4) assessment of adherence to label indication in the post approval setting (using assessment of baseline characteristics) and 5) assessment of stroke in the post approval setting. Study patients will undergo clinical follow-up at discharge, 30 days, 1 year and then annually for a minimum of 5 years (TVT national registry-CMS Linkage).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Assessment of Safety, Effectiveness, Adherence to Indication and Learning Curve of the SAPIEN™ THV With Retroflex for Inoperable Patients and With RetroFlex or Ascendra for High Risk Operable Patients Post Approval Period (US)
Actual Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inoperable and high risk operable
SAPIEN valve with the Retroflex delivery system or the Ascendra delivery system
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Inoperable and high risk operable patients requiring the transcatheter aortic heart valve replacement




Primary Outcome Measures :
  1. The clinical event of stroke [ Time Frame: 30 days ]
  2. The clinical event of stroke [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. VARC composite safety -Major vascular complications -Stroke [ Time Frame: 30 days ]

    VARC composite safety:

    • All cause mortality
    • Stroke
    • Life-threatening (or disabling) bleeding
    • Acute kidney injury - Stage 3 (including renal replacement therapy)
    • Peri-procedural MI
    • Repeat procedure for valve related dysfunction

      • Major vascular complications
      • Stroke

  2. VARC composite safety -Major vascular complications -Stroke [ Time Frame: 1 year ]

    VARC composite safety:

    • All cause mortality
    • Stroke
    • Life-threatening (or disabling) bleeding
    • Acute kidney injury - Stage 3 (including renal replacement therapy)
    • Peri-procedural MI
    • Repeat procedure for valve related dysfunction

      • Major vascular complications
      • Stroke



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet the fundamental enrollment criteria of severe, symptomatic, calcific aortic stenosis with quantifiable and documented source records
  • Upon meeting these eligibility criteria, the heart team shall then determine the patient's risk for operative morbidity and mortality
  • Details of eligibility including contraindications are provided in the product Instructions for Use which are included with each SAPIEN™ THV and delivery system.

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02184442     History of Changes
Other Study ID Numbers: 2011-THV-01-US /2012-THV-01-US
PMA # P110021 and P100041 ( Other Identifier: FDA )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Edwards Lifesciences:
SAPIEN
TAVR
THV
Aortic Stenosis
Heart Valve Disease
Aortic Valve
Retroflex
Ascendra

Additional relevant MeSH terms:
Aortic Valve Stenosis
Calcinosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases