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Trial record 2 of 6 for:    INTERMACS® heartware

Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials (HW-PAS-03)

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ClinicalTrials.gov Identifier: NCT01832610
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

Condition or disease Intervention/treatment
Heart Failure Device: HeartWare® VAS

Detailed Description:

Patients who participated in prior trials will be approached for this PAS as follows:

  • Patients who are on continued HeartWare® System support, (original or exchange device)
  • Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up

Patients who participated in prior trials who will not be approached to participate in this follow-up study include:

• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).

No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.


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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
HeartWare® VAS
Ventricular Assist Device (HeartWare® VAS)
Device: HeartWare® VAS
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Other Name: HVAD®




Primary Outcome Measures :
  1. Overall Survival on Device [ Time Frame: Implant to 5 years ]
    Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.


Secondary Outcome Measures :
  1. Final Patient Status [ Time Frame: Implant to 5 years ]
    The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.

  2. Re-hospitalizations [ Time Frame: Enrollment into HW-PAS-03 to 5 years ]
    A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.

  3. Number of Participants Experiencing Any Adverse Event Per Intermacs Definition [ Time Frame: Enrollment into HW-PAS-03 to 5 years ]
    Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.

  4. Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Change from baseline to 5 years ]
    Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.

  5. Health Status Change Measured by EuroQol EQ-5D (Version 5L) [ Time Frame: Enrollment to 5 years ]
    The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).

  6. Change in Functional Status Measured by New York Heart Association (NYHA) Class [ Time Frame: Change from baseline to 5 years ]

    Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:

    I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

    II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

    III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

    Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).


  7. Change in Functional Status Measured by 6-minute Walk [ Time Frame: Change from baseline to 5 years ]
    Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patient population consists of patients who were at risk of death from refractory, advanced heart failure and implanted with a HeartWare® Ventricular Assist System under IDE G070199.

Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, and been implanted with the HeartWare® System

Criteria

Inclusion Criteria:

  1. The patient has participated in a prior HeartWare trial under IDE G070199.
  2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
  3. The patient has signed informed consent for participation in the study.

Exclusion Criteria:

  1. The patient is unwilling or unable to comply with trial requirements.
  2. The patient did not sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832610


  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Study Protocol  [PDF] September 4, 2013
Statistical Analysis Plan  [PDF] August 8, 2017


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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01832610     History of Changes
Other Study ID Numbers: HW-PAS-03
First Posted: April 16, 2013    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases