Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02877446 |
| Other study ID # |
9690 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
August 10, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chronic heart failure is a common disease. It is also a serious disease with a mortality of
50% at 5 years, representing a significant cost in terms of public health expenditure.
Heart transplantation represents the "gold standard" of care for terminal heart failure
patients reached the end of the disease despite optimal medical and surgical management of
their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3
years.
Long term LVAD are an innovative technology available for more than a decade, developed in
part because of the shortage of cardiac grafts and high mortality among patients waiting for
transplants due to an important pending.
This technique is used substantially only for ten to fifteen years in the world. Survival
after implantation of latest devices reaches 80% at 1 year.
In France, this technique is intended for patients with terminal heart failure who ended
different pharmacological and invasive therapeutic resources available.
Currently, academic centers that offer the possibility of long-term LVAD support are
organized unicentric in order to centralize specialized care for these patients.
Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected
to ensure an acceptable survival.
However, practices vary considerably from one center to another in particular regarding:
- Implantation indications,
- Pre-implantation patient assessment,
- Monitoring,
- Implementation of pharmacological treatments, particularly anticoagulants or
betablockers.
Description:
Methods:
It's a prospective multicentric observational study realised on 3 University Hospital in
France: Bordeaux, Montpellier and Toulouse.
Population:
All patients undergoing implantation of a long-term LVAD support whatever the brand and type,
on one of the 3 participating centers (Montpellier, Toulouse or Bordeaux) during the 3 years
period, after approval of informed consent.
Patients were followed up at 1 and 6 months, and 1 year as part of their routine management
of their disease.
Patients should have agreed to participate in the observatory, knowing that participation or
refusal to participate will not alter the therapeutic attitude of the team responsible for
the patient.
Aim:
Main aim is 1 year mortality of LVAD recipients
Secondary aim are:
- Descriptive epidemiology of LVAD implantation: prevalence, etiology, affected
populations
- Description of the state of practice: indications, against-indications, preimplantation
data, intraoperative data, postoperative data, tracking data
- Rating prognosis of patients under LVAD support
- In-hospital, 30 days, 6 months, and 1 year survival
- Number of transplanted and assisted patients at 1 year
- Evaluation of complications (infections, bleeding, thromboembolism, equipment failures,
...)
- Analyses in subgroups according to age, sex, initial indication (including ischemic
heart disease vs nonischemic), assistance used and year of implantation
- Research of prognostic factors for postoperative and chronic right ventricular failure,
prognostic factors of cardiovascular and all causes death.
Feasibility:
Based on historical data of the concerned centers (CHU Montpellier, Bordeaux and Toulouse)
and recent predictions of french health authority HAS ("Haute Autorité de Santé"), 200
patients are provided in the observatory register, rhythm about 20-30 patients per year per
center for a 3-year recruitment period Monitoring will be carried out by the referring
physician for each patient at 1 and 6 months, and at 1 year in the usual care of pathology in
each center with the possibility to adapt the follow-up date to +/- 1 month.
For patients who have moved and have therefore changed of referral center, an evaluation at
one year will be made by mail or phone contact with the physician and / or patient.
Collect and circulation of patients' data:
Data will be collected under the patient's referring physician's responsibility in each
center. Data will be entered directly into the electronic database (e-CRF) developed
University of Montpellier.
Patient will be identified by the number of the center (1 = Bordeaux, 2 = Montpellier 3 =
Toulouse) followed by the first letter of the name and the first initial and the center of
the patient number in question (automatic chronological number according to the entry on the
e-CRF - data coding is integrated into the e-CRF) Monitoring at 1 month, 6 months and 1 year,
will be completed by the middle of referring physicians and entered directly into the
electronic database.
There will be no traffic data on paper for these two steps.
In case of lost sight, follow-up at 1 year will be carried out by the centers, by phone or
mail from the municipality of birth, the attending physician or cardiologist and patient,
which requires knowledge of the date full birth patients to avoid confusion.
For the analysis, data will be anonymized (as shown above).
Members of the scientific committee, persons responsible for logistics and coordination
statistics will have access to all of the identified data.
Research data is entered via an electronic case report forms (e-CRF) developed from the
Capture System software (CLINSIGHT company), enabling quality control of data in real time.
To meet regulatory requirements, this software complies with the FDA's recommendations on
Computerized Systems for Managing Clinical Trials and electronic signature and standards
(CDISC, ICH, GCP 2001/20 / EC ...). The connection is via a password and a unique identifier
specific to each user that will give access only to his patients himself. An audit function
is integrated allowing traceability of data as well as changes. The encrypted data will then
be transmitted to the responsible center of the data-management via a secure internet
connection.
The e-CRF must be composed of all the information required by the protocol.
Information and Consent of participants:
Prior to the completion of this research, the free, writing and informed consent of patients
must be collected after information by the investigator during a consultation, and after a
sufficient period of reflection.
Participants information for research should be written simply, in language understandable by
the patient. After having read the participant and the investigator will have dated and
signed the consent form (original archived by the investigator and an original will be given
to research participants).
