Heart FailureP5NCT02543632
PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.
An observational study of Heart Failure and Left Ventricular Dysfunction, run by CardioKinetix, Inc at 10 sites in Germany.
Trial summary
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Dysfunction
- What is being tested?
- Parachute Implant System
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 10 sitesGermany
- Study dates
- Aug 2015to Jun 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at least 18 years of age with symptoms of heart failure and anteroapical wall motion abnormality due to myocardial infarction.
Who may be able to join
- Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
- Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
- Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
- >18 years of age
- Provide written informed consent
- Agree to the protocol-required follow-up
Who cannot join
- Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
- Cardiogenic shock within 72 hours of enrollment
- A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
- Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
- Co-morbidities associated with a life expectancy of less than 12-months
- Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Uniklinik Aachen
Aachen, 52074
Kerckhoff-Klinik gGmbH
Bad Nauheim, 61231
Unfalkrankenhaus Berlin
Berlin
University Köln
Cologne, 50937
Cardiac Research GmbH
Dortmund, Hohe Straße 1, Dortmund
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, Moorenstr. 5, 40225
Universitätsklinikum Erlangen
Erlangen, 91054
Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
Essen, Klara-Kopp-Weg 1, 45138
Asklepios Klinik St. George
Hamburg, 20099
Universitäres Herzzentrum Hamburg Eppendorf GmbH
Hamburg, 20251
About this study
Official title: PARACHUTE V: PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
Read the detailed description
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Being tested
- Parachute Implant System
- Keywords
- heart failure, parachute, partitioning device
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parachute Implant SystemDevice
Also called Parachute Device
The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Subjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System. Receives: Device: Parachute Implant System | |
| Control group | Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire.
Measured: 6 months
Secondary outcomes (1)
Stroke Volume Index
An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
Measured: 0 days (at implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Company closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- CardioKinetix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helge Möllmann, MD, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543632
- Sponsor's protocol ID
- RD1591
- Acronym
- P5
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARACHUTE V: PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System
- ClinicalTrials.gov ID
- NCT02543632
- Acronym / sponsor ID
- P5 / RD1591
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Keywords
- heart failure, parachute, partitioning device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company closed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- CardioKinetix, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
Detailed description
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | – | Device: Parachute Implant SystemSubjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System. |
| Control group | – | –Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at least 18 years of age with symptoms of heart failure and anteroapical wall motion abnormality due to myocardial infarction.
Key inclusion criteria (6 listed)
- Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
- Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
- Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
- >18 years of age
- Provide written informed consent
Key exclusion criteria (6 listed)
- Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
- Cardiogenic shock within 72 hours of enrollment
- A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
- Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
- Co-morbidities associated with a life expectancy of less than 12-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parachute Implant SystemAlso: Parachute DeviceThe CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle. | Device | Treated group |
Primary outcome
Quality of Life
Time frame: 6 months
An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire.
1 secondary outcome
Stroke Volume Index
Time frame: 0 days (at implant)
Results and safety
The study was stopped early (reason given: Company closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Möllmann, MD principal investigator
Kerckhoff Klinik
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Left Ventricular Dysfunction, run by CardioKinetix, Inc at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.