Class IV AnginaNCT01845103
The PEARL 8.0 Post-Approval Study
An observational study of Class IV Angina, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. at 1 site in United States.
Trial summary
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Class IV Angina
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: A minimum of two and a maximum of five study sites will be selected for participation. The sites (surgeons) will be selected first from those that participated in the PEARL Study TMR 05-001. If additional sites are required, selection will be made for the sites (surgeons) to be familiar with TMR and thoracoscopic surgery. Sites will be asked to offer all patients eligible for stand-alone thoracoscopic TMR, who meet the inclusion/exclusion criteria, the opportunity to participate in the current study.
Who may be able to join
- Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
- Ejection Fraction > 30%
- Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA).
- Patients amenable to thoracoscopic TMR.
Who cannot join
- Age less than18-years
- Pregnant or nursing mothers
- Unable to undergo a surgical procedure or general anesthesia
- Hepatic disease, renal failure, cancer or major infection
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48- hours)
- Patients with mechanical/prosthetic heart valves
Show all 11Show fewer
- Myocardial ischemia limited to the right ventricular wall
- Q-Wave myocardial infarction within three (3) weeks prior to the procedure
- Non Q-Wave myocardial infarction within two (2) weeks prior to the procedure
- Requires anticoagulation medications or has other hemorrhagic propensity
- Severe arrhythmia within one week prior to the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Sutter Institute for Medical Research
Sacramento, California, 95816
About this study
Official title: Post-Approval Study of the PEARL 8.0 Handpiece for Transmyocardial Revascularization (TMR) With the Cardiogenesis Holmium:YAG Laser System
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
Read the detailed description
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The PEARL 8.0 Handpiece allows the TMR laser energy to be directed at the heart through a small port up to 8 mm in size. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who receive this device is less than the historical rate plus a non-inferiority margin. In a recent study of 34 patients treated with the PEARL 8.0 device, 3 (8.8%) experienced 30 day mortality. Among 132 patients in the original PMA trial treated with the SoloGrip III Handpiece, a similar device delivering identical energy, the 30 day mortality rate was 5.3% (7/132). In the Post-Approval Study of the SoloGrip III Handpiece, 2/72 prospectively enrolled patients died within the first 30 days. Therefore, the weighted average of the Pre-market and post-market studies has been calculated (4.4%) and will serve as the historical rate.
This trial will be monitored for success and futility according to a Bayesian adaptive design. Based on prior history, we assume patients will be accrued at the rate of approximately 1 patient per month and therefore, 30 day mortality will be known for all currently enrolled patients at the time each new patient is enrolled.
The success stopping boundaries for this study are 0/10 and 1/22. Thus, if no deaths are observed among the first 10 patients, the study will stop for success. If 1 death is observed among the first 10 patients, the study will continue to enroll. If among the first 22 patients, only 1 death is observed (there are no additional deaths), the study will stop for success. At any time, if 2 or more deaths are observed, the study will stop for futility.
A secondary objective is to assess the effect of channel number on the 30 day mortality rate to justify the labeling claims that the risk for early post-operative (30 day) mortality is associated with an increased number of channels, and not the function of the operation or device.
- Conditions
- Class IV Angina
- Keywords
- ANGINA, Thoracoscopic
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 day
Secondary outcomes (1)
Major Adverse Coronary and Cerebrovascular Events (MACCE)
MACCE includes:
Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Due to the product being discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Class IV AnginaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Capps, MS, Study director, CryoLife, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845103
- Sponsor's protocol ID
- PLT1101.003-M
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2013
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the PEARL 8.0 Handpiece for Transmyocardial Revascularization (TMR) With the Cardiogenesis Holmium:YAG Laser System
- ClinicalTrials.gov ID
- NCT01845103
- Acronym / sponsor ID
- PLT1101.003-M
- Conditions
- Class IV Angina
- Keywords
- ANGINA, Thoracoscopic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the product being discontinued
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 30 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
Detailed description
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The PEARL 8.0 Handpiece allows the TMR laser energy to be directed at the heart through a small port up to 8 mm in size. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who receive this device is less than the historical rate plus a non-inferiority margin. In a recent study of 34 patients treated with the PEARL 8.0 device, 3 (8.8%) experienced 30 day mortality. Among 132 patients in the original PMA trial treated with the SoloGrip III Handpiece, a similar device delivering identical energy, the 30 day mortality rate was 5.3% (7/132). In the Post-Approval Study of the SoloGrip III Handpiece, 2/72 prospectively enrolled patients died within the first 30 days. Therefore, the weighted average of the Pre-market and post-market studies has been calculated (4.4%) and will serve as the historical rate.
This trial will be monitored for success and futility according to a Bayesian adaptive design. Based on prior history, we assume patients will be accrued at the rate of approximately 1 patient per month and therefore, 30 day mortality will be known for all currently enrolled patients at the time each new patient is enrolled.
The success stopping boundaries for this study are 0/10 and 1/22. Thus, if no deaths are observed among the first 10 patients, the study will stop for success. If 1 death is observed among the first 10 patients, the study will continue to enroll. If among the first 22 patients, only 1 death is observed (there are no additional deaths), the study will stop for success. At any time, if 2 or more deaths are observed, the study will stop for futility.
A secondary objective is to assess the effect of channel number on the 30 day mortality rate to justify the labeling claims that the risk for early post-operative (30 day) mortality is associated with an increased number of channels, and not the function of the operation or device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of two and a maximum of five study sites will be selected for participation. The sites (surgeons) will be selected first from those that participated in the PEARL Study TMR 05-001. If additional sites are required, selection will be made for the sites (surgeons) to be familiar with TMR and thoracoscopic surgery. Sites will be asked to offer all patients eligible for stand-alone thoracoscopic TMR, who meet the inclusion/exclusion criteria, the opportunity to participate in the current study.
Key inclusion criteria (4 listed)
- Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
- Ejection Fraction > 30%
- Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA).
- Patients amenable to thoracoscopic TMR.
Key exclusion criteria (11 listed)
- Age less than18-years
- Pregnant or nursing mothers
- Unable to undergo a surgical procedure or general anesthesia
- Hepatic disease, renal failure, cancer or major infection
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48- hours)
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
Mortality
Time frame: 30 day
1 secondary outcome
Major Adverse Coronary and Cerebrovascular Events (MACCE)
Time frame: 30 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott B Capps, MS study director
CryoLife, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class IV Angina, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. at 1 site in United States.
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 4 inclusion and 11 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (time frame: 30 day). 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 6 Oct 2016.