Pulmonary Valve InsufficiencyNCT00676689
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
A study testing SAPIEN Transcatheter Valve Implantation in people with Pulmonary Valve Insufficiency and Pulmonary Regurgitation, run by Edwards Lifesciences at 7 sites in United States.
Trial summary
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit
- What is being tested?
- SAPIEN Transcatheter Valve Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Apr 2008to 31 Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight must be equal to or exceed 35 kilograms.
- In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
- Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
- Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
- Catheterization is determined to be feasible by the treating physician.
Who cannot join
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- Previously enrolled in this study.
- Subject with pre-existing prosthetic heart valves in any position*.
- Severe chest wall deformity.
- Leukopenia (WBC<3000 mm3).
- Acute or chronic anemia (Hb <9 g/dL).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48130
Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30341
Rush Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Miami Children's Hospital
Miami, Florida, 33155
Children's Hospital of New York
New York, New York, 10032
About this study
Official title: Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.
Read the detailed description
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis
- Being tested
- SAPIEN Transcatheter Valve Implantation
- Keywords
- Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect
- Medical subject headings
- Pulmonary Valve Insufficiency, Airway Obstruction, Pulmonary Valve Stenosis, Gastroesophageal Reflux, Constriction, Pathologic, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN Transcatheter Valve ImplantationDevice
Device Implantation
| Study group | Role | What they receive |
|---|---|---|
| SAPIEN THV | Experimental | Not described Receives: Device: SAPIEN Transcatheter Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Device or Procedure Related Death or Reintervention
Measured: 1 year
Secondary outcomes (2)
Freedom From MACCE
Clinical Events Committee (CEC) adjudicated.
Measured: 6 Months
Functional Improvement
Functional improvement at 6 months as defined by:
- Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study start8 Apr 2008
- Primary completionNov 2015
- Study completion31 Dec 2019
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 Pulmonary Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ziyad M Hijazi, M.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676689
- Sponsor's protocol ID
- 2006-09
- Status last verified
- Feb 2020
- First submitted
- 9 May 2008
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
- ClinicalTrials.gov ID
- NCT00676689
- Acronym / sponsor ID
- 2006-09
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis
- Keywords
- Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2008 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 1 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.
Detailed description
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAPIEN THV | Experimental | Device: SAPIEN Transcatheter Valve Implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Weight must be equal to or exceed 35 kilograms.
- In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
- Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
- Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Key exclusion criteria (6 listed)
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- Previously enrolled in this study.
- Subject with pre-existing prosthetic heart valves in any position*.
- Severe chest wall deformity.
- Leukopenia (WBC<3000 mm3).
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 |
|---|---|---|
| SAPIEN Transcatheter Valve ImplantationDevice Implantation | Device | SAPIEN THV |
Primary outcome
Freedom From Device or Procedure Related Death or Reintervention
Time frame: 1 year
2 secondary outcomes
Freedom From MACCE
Time frame: 6 Months
Functional Improvement
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ziyad M Hijazi, M.D. principal investigator
Rush University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAPIEN Transcatheter Valve Implantation in people with Pulmonary Valve Insufficiency and Pulmonary Regurgitation, run by Edwards Lifesciences at 7 sites 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 7 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: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 1 Sep 2016). 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?
Freedom From Device or Procedure Related Death or Reintervention (time frame: 1 year). 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 26 Feb 2020.