Long-term outcomes after LVAD implantation for end-stage heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational, multicenter cohort enrolling adults with end-stage heart failure who undergo LVAD implantation as part of routine care. Investigators will collect baseline, preoperative, intraoperative, and in-hospital information and then track postoperative medications, survival status, major clinical events, LVAD-related complications, and hospital readmissions for 3–5 years. Left ventricular apical myocardial tissue (routinely removed during surgery) and peripheral blood samples collected during clinical care will be banked for future molecular and pathologic analyses. No experimental treatments are given; the goal is to describe real-world long-term outcomes and identify factors associated with survival and complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged ≥18 years
2. Diagnosis of end-stage heart failure refractory to optimal medical therapy
3. Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care
4. Able to provide written informed consent for participation and biospecimen collection
5. Willing and able to comply with study procedures and long-term follow-up
6. Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery
7. Availability of peripheral blood samples collected during routine clinical care
8. Patients treated at participating study centers

Exclusion Criteria:

1. Age \<18 years
2. Prior implantation of a durable mechanical circulatory support device
3. Concomitant heart transplantation at the time of index surgery
4. Congenital heart disease requiring complex surgical repair
5. Active systemic infection or sepsis at the time of LVAD implantation
6. Known active malignancy with a life expectancy \<1 year
7. Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)
8. Inability or unwillingness to provide informed consent
9. Pregnancy or breastfeeding at the time of enrollment
10. Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses

Where it's running

• +86 025 83106666
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Tuo Pan, M.D
• Email: pan_tuo@126.com
• Phone: +86 15205160210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of Impella 5.5 on heart function in adults with end-stage heart failure

  This study tests whether the Impella 5.5 helps the heart’s two sides work better in adults with severe heart failure who need temporary support.

  Recruiting University of Rochester · Rochester, New York · NCT07534462

• Comparing LVAD and medical therapy for advanced heart failure patients

  This study tests whether the HeartMate 3 device can help people with severe heart failure feel better and live healthier lives compared to standard medical treatments.

  Recruiting at 8 sites Hospices Civils de Lyon · Besançon and 7 other locations · NCT04768322

• Noninvasive monitoring of heart function in patients with LVADs

  This study is testing new ways to monitor heart function in people with a HeartMate 3 LVAD to see if they can get better information than the usual methods like echocardiograms and ECGs.

  Recruiting Medical University of Vienna · Vienna · NCT04641416

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.