Tetralogy of FallotNCT00112320
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
A study testing PVR plus RV remodeling and Standard PVR in people with Tetralogy of Fallot and Pulmonary Valve Insufficiency, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
- What is being tested?
- PVR plus RV remodeling and Standard PVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Aug 2011
- Phase
- Interventional
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing PVR to repair TOF at Children's Hospital Boston
- Pulmonary regurgitation fraction greater than or equal to 25% (measured by CMR) and two or more of the following criteria:
- RV end-diastolic volume index greater than or equal to 150 ml/m2 (Z score greater than 5)
- RV end-systolic volume index greater than or equal to 70 ml/m2
- LV end-diastolic volume index less than or equal to 65 ml/m2
- RV ejection fraction less than 45%
- RVOT aneurysm
- Clinical criteria: exercise intolerance, symptoms and signs of heart failure, and use of cardiac medications
Who cannot join
- Presence of either severe RV outflow tract obstruction (defined as peak-to-peak systolic gradient of greater than or equal to 60 mm Hg by cardiac catheterization) or severe RV hypertension at systemic or higher level
- Additional sources of RV volume overload other than PR and tricuspid valve regurgitation
- Contraindications to CMR
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Cardiology, Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement [PVR]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.
Read the detailed description
Background:
Surgical repair of TOF often results in chronic pulmonary regurgitation (PR) with associated RV dilatation and dysfunction. Mounting evidence indicates that PR leads to significant long-term morbidity and mortality, including arrhythmias, sudden death, and right heart failure. Using CMR, there is a high prevalence of regional dysfunction and aneurysms in the RV in patients with repaired TOF. Current standard clinical practice in patients with repaired TOF, severe PR, ventricular dysfunction, and/or clinical deterioration is to insert a bioprosthetic pulmonary valve to reduce the volume load on the RV. Although PVR can be achieved with low mortality, research has shown a persistent or worsening RV dysfunction postoperatively, despite a competent pulmonary valve. In patients with left ventricular (LV) aneurysms, surgical remodeling with aneurysm resection has been shown to improve LV mechanics. In view of the potentially deleterious effects of aneurysmal and akinetic wall segments on RV mechanics, researcher have recently modified their PVR surgical technique in selected patients to include surgical remodeling of the RV with resection of the akinetic wall segments. However, no studies have systematically compared the efficacy of PVR plus surgical RV remodeling to PVR alone.
Research Question:
Is there a difference between two surgical strategies-PVR alone (bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract [RVOT] aneurysm) versus PVR and surgical RV remodeling (bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume)-on RV mechanics and on the incidence of adverse events in patients with repaired TOF and chronic pulmonary regurgitation?
- Being tested
- PVR plus RV remodeling, Standard PVR
- Keywords
- Pulmonary Valve Regurgitation, Right Ventricular Dysfunction, Heart Diseases
- Medical subject headings
- Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVR plus RV remodelingProcedure or surgery
PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume
Standard PVRProcedure or surgery
PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard PVR Receives: Procedure: Standard PVR |
| 2 | Experimental | PVR plus RV remodeling Receives: Procedure: PVR plus RV remodeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ventricular mechanics compared with the preoperative ventricular mechanics
Measured: Measured at 6 months
Secondary outcomes (1)
Incidence of one or more postoperative adverse events
Measured: Measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Judith Geva, Boston Children's Hospital
- Investigators
- Tal Geva, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112320
- Sponsor's protocol ID
- 188
- Other IDs
- P50HL074734, P50HL074734-01
- Status last verified
- Dec 2012
- First submitted
- 1 Jun 2005
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Geva T, Gauvreau K, Powell AJ, Cecchin F, Rhodes J, Geva J, del Nido P. Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery. Circulation. 2010 Sep 14;122(11 Suppl):S201-8. doi: 10.1161/CIRCULATIONAHA.110.951178.
PubMed 20837914
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT00112320
- Acronym / sponsor ID
- 188
- Keywords
- Pulmonary Valve Regurgitation, Right Ventricular Dysfunction, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2004
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Jun 2005 (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.
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement [PVR]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.
Detailed description
Background:
Surgical repair of TOF often results in chronic pulmonary regurgitation (PR) with associated RV dilatation and dysfunction. Mounting evidence indicates that PR leads to significant long-term morbidity and mortality, including arrhythmias, sudden death, and right heart failure. Using CMR, there is a high prevalence of regional dysfunction and aneurysms in the RV in patients with repaired TOF. Current standard clinical practice in patients with repaired TOF, severe PR, ventricular dysfunction, and/or clinical deterioration is to insert a bioprosthetic pulmonary valve to reduce the volume load on the RV. Although PVR can be achieved with low mortality, research has shown a persistent or worsening RV dysfunction postoperatively, despite a competent pulmonary valve. In patients with left ventricular (LV) aneurysms, surgical remodeling with aneurysm resection has been shown to improve LV mechanics. In view of the potentially deleterious effects of aneurysmal and akinetic wall segments on RV mechanics, researcher have recently modified their PVR surgical technique in selected patients to include surgical remodeling of the RV with resection of the akinetic wall segments. However, no studies have systematically compared the efficacy of PVR plus surgical RV remodeling to PVR alone.
Research Question:
Is there a difference between two surgical strategies-PVR alone (bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract [RVOT] aneurysm) versus PVR and surgical RV remodeling (bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume)-on RV mechanics and on the incidence of adverse events in patients with repaired TOF and chronic pulmonary regurgitation?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Standard PVRStandard PVR |
| 2 | Experimental | Procedure: PVR plus RV remodelingPVR plus RV remodeling |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Undergoing PVR to repair TOF at Children's Hospital Boston
- Pulmonary regurgitation fraction greater than or equal to 25% (measured by CMR) and two or more of the following criteria:
Key exclusion criteria (3 listed)
- Presence of either severe RV outflow tract obstruction (defined as peak-to-peak systolic gradient of greater than or equal to 60 mm Hg by cardiac catheterization) or severe RV hypertension at systemic or higher level
- Additional sources of RV volume overload other than PR and tricuspid valve regurgitation
- Contraindications to CMR
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 |
|---|---|---|
| PVR plus RV remodelingPVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume | Procedure or surgery | 2 |
| Standard PVRPVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm | Procedure or surgery | 1 |
Primary outcome
Changes in ventricular mechanics compared with the preoperative ventricular mechanics
Time frame: Measured at 6 months
1 secondary outcome
Incidence of one or more postoperative adverse events
Time frame: Measured at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 20837914Geva T, Gauvreau K, Powell AJ, Cecchin F, Rhodes J, Geva J, del Nido P. Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery. Circulation. 2010 Sep 14;122(11 Suppl):S201-8. doi: 10.1161/CIRCULATIONAHA.110.951178.
- Click here for the Children's Hospital Boston Cardiovascular Program web siteLink provided by the sponsor.
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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.
Tal Geva, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVR plus RV remodeling and Standard PVR in people with Tetralogy of Fallot and Pulmonary Valve Insufficiency, run by Boston Children's Hospital 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 8 inclusion and 3 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 4 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in ventricular mechanics compared with the preoperative ventricular mechanics (time frame: Measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112320, which also lists 1 linked publication.
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 4 Dec 2012.