Heart FailurePIII PV LoopNCT02241837
PARACHUTE III Pressure Volume Loop Sub-Study
An observational study of Heart Failure and Myocardial Infarction, run by CardioKinetix, Inc at 3 sites in 3 countries.
Trial summary
The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure, Myocardial Infarction
- How many people
- 11 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2013to Jun 2017
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.
Who may be able to join
- Candidates for this study must meet ALL of the following inclusion criteria:
- Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
- Subject is not hospitalized at time of enrollment.
- NYHA Class at time of enrollment, either:
- NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment
- NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
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- LVEF >15 or% and ≤ 40% as measured by echocardiography.
- Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
- Eligible for cardiac surgery
- Between 18 and 79 years of age (inclusive)
- Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
- Provide written informed consent
- Agree to the protocol-required follow-up
Who cannot join
- Candidates will be excluded from the study if ANY of the following conditions apply:
- Untreated clinically significant coronary artery disease requiring intervention.
- Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
- Cardiogenic shock within 72 hours of enrollment
- Revascularization procedure (PCI or CABG) within 60 days of enrollment
- Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
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- History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
- A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
- Aortic valve replacement or repair
- Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Active peptic ulcer or GI bleeding within the past 3 months
- Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
- History of Kawasaki's disease
- Patient on dialysis or expected to require hemodialysis within 12 months
- Patient has chronic liver disease
- Impaired renal function that places patient at risk of contrast induced renal failure
- Ongoing sepsis, including active endocarditis.
- Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System
The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease. This sub-study has the additional assessment of improvement in Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure and volume as functional parameters of the Left Ventricle.
Read the detailed description
While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the longterm safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.
- Conditions
- Heart Failure, Myocardial Infarction
- Keywords
- heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis, myocardial infarction
- Medical subject headings
- Heart Failure, Myocardial Infarction, Dyskinesias
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of long term safety of the Parachute system from baseline to 1 year and annually
Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.
Measured: 5 years
Secondary outcomes (1)
Change in Left Ventricular Volume Indices between baseline, 6 months, and annually
Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years
Measured: 6 months and annually to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJun 2017
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 only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioKinetix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Redwood, MD, Principal investigator, St. Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241837
- Sponsor's protocol ID
- RD1051.B.3
- Acronym
- PIII PV Loop
- Status last verified
- Jun 2017
- First submitted
- 12 Sep 2014
- 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 III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System
- ClinicalTrials.gov ID
- NCT02241837
- Acronym / sponsor ID
- PIII PV Loop / RD1051.B.3
- Conditions
- Heart Failure, Myocardial Infarction
- Keywords
- heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis, myocardial infarction
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CardioKinetix, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 2014 (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.
The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease. This sub-study has the additional assessment of improvement in Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure and volume as functional parameters of the Left Ventricle.
Detailed description
While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the longterm safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.
Key inclusion criteria (13 listed)
- Candidates for this study must meet ALL of the following inclusion criteria:
Key exclusion criteria (18 listed)
- Untreated clinically significant coronary artery disease requiring intervention.
- Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
- Cardiogenic shock within 72 hours of enrollment
- Revascularization procedure (PCI or CABG) within 60 days of enrollment
- Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of long term safety of the Parachute system from baseline to 1 year and annually
Time frame: 5 years
Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.
1 secondary outcome
Change in Left Ventricular Volume Indices between baseline, 6 months, and annually
Time frame: 6 months and annually to 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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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.
Simon Redwood, MD principal investigator
St. Thomas' Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Myocardial Infarction, run by CardioKinetix, Inc at 3 sites in 3 countries.
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 13 inclusion and 18 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 3 sites in Belgium, Italy, United Kingdom. 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. 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?
Assessment of long term safety of the Parachute system from baseline to 1 year and annually (time frame: 5 years). 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.