Mitral Valve FailureNCT03015194
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
A study testing Edwards SAPIEN 3 transcatheter heart valve and ASHI INTECC Astato XS 20 in people with Mitral Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 sites in United States.
Trial summary
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Failure
- What is being tested?
- Edwards SAPIEN 3 transcatheter heart valve and ASHI INTECC Astato XS 20
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Jun 2017to 13 Apr 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age greater than or equal to 21 years
- Severe symptomatic native mitral valve failure after mitral annuloplasty repair or related to mitral annular calcification.
- Unacceptably high or prohibitive risk for surgical mitral valve replacement and indicated for transcatheter mitral valve replacement (TMVR) as determined by the multidisciplinary institutional heart team, including at least one cardiovascular surgeon who has examined the patient.
- High or prohibitive risk of LVOT obstruction (predicted neo-LVOT less than 200 mm2) or transcatheter heart valve dysfunction from long/redundant anterior mitral valve leaflet, as determined by the multidisciplinary institutional heart team.
- Anatomic eligibility for LAMPOON based on core lab assessment of the baseline CT and echocardiogram.
- Concordance of the study selection team
Who cannot join
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- Predicted neo-LVOT created by the Sapien-3 skirt, after LAMPOON, less than 150 mm2
- TAVR within 6 weeks
- Intended concurrent structural heart procedure, such as aortic or tricuspid valve implantation
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322-1102
Henry Ford Hospital
Detroit, Michigan, 48202
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Carilion Medical Center
Roanoke, Virginia, 24014
University of Washington Division of Cardiology
Seattle, Washington, 98195
Medstar Washington Hospital Center, Cardiovascular Research Program
Washington D.C., District of Columbia, 20010
About this study
Background:
Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants in this study will be among the first in the world to have this technique done.
Read more
Objectives:
To test the safety and effectiveness of the LAMPOON technique in TMVR.
Eligibility:
Adults ages 21 and over who are recommended to have TMVR with LAMPOON
Design:
Participants will be screened with medical history and exam and by review of medical records.
Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the procedure.
Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of the way before inserting the artificial mitral valve.
Participants will recover in an inpatient recovery unit.
They will repeat the previous tests before leaving the hospital, 1 month later, 6 months later and 1 year later. They will have yearly follow-up phone calls for about 5 years.
In the event of a participant's death, researchers will ask for an autopsy and to analyze the heart. Permission for this is not required as part of the study.
Read the detailed description
Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. For these patients the only options appear to avoid TMVR or in some to cause a focused heart attack and to wait 6 weeks. The investigators have developed and tested a technique to split the existing mitral valve leaflet and enable TMVR in patients who have no other options. The procedure is called intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices commercially available, there has been short-term success with implanted transcatheter aortic valve devices in the mitral position for TMVR.
The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options to treat their mitral valve failure, using heart valve devices designed to implant in the aortic valve position.
- Conditions
- Mitral Valve Failure
- Being tested
- Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
- Keywords
- LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis
- Medical subject headings
- Bites and Stings, Mitral Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards SAPIEN 3 transcatheter heart valveDevice
Used to relieve aortic stenosis in patients with symptomatic heart disease
In this study it is not used for aortic stenosis-----the device is used in the mitral valve position.
ASHI INTECC Astato XS 20Device
The Astato 0.014" guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step.
| Study group | Role | What they receive |
|---|---|---|
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Experimental | The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography. Receives: Device: Edwards SAPIEN 3 transcatheter heart valve; Device: ASHI INTECC Astato XS 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:
- Successful LAMPOON traversal and laceration; and
- Peak LVOT gradient < 50 mm Hg; and
- Absence of procedural mortality; and
- Successful access, delivery, and retrieval of the LAMPOON device system; and
- Successful deployment and correct positioning of the first intended device; and
- Freedom from emergency surgery or reintervention related to the device or access procedure.
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Measured: Exit from the Cardiac Catheterization Laboratory
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:
- Successful LAMPOON traversal and laceration; and
- Peak LVOT gradient < 30 mm Hg; and
- Absence of procedural mortality; and
- Successful access, delivery, and retrieval of the LAMPOON device system; and
- Successful deployment and correct positioning of the first intended device; and
- Freedom from emergency surgery or reintervention related to the device or access procedure.
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Measured: Exit from the Cardiac Catheterization Laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start20 Jun 2017
- Primary completion26 Jul 2018
- Study completion13 Apr 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve FailureStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015194
- Sponsor's protocol ID
- 999917032
- Other IDs
- 17-H-N032
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2017
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Khan JM, Babaliaros VC, Greenbaum AB, McCabe JM, Rogers T, Eng MH, Foerst JR, Yazdani S, Paone G, Gleason PT, Halaby RN, Bruce CG, Tian X, Stine AM, Lederman RJ. 5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2157-2167. doi: 10.1016/j.jcin.2024.05.041. Epub 2024 Sep 4.
PubMed 39243268Khan JM, Babaliaros VC, Greenbaum AB, Foerst JR, Yazdani S, McCabe JM, Paone G, Eng MH, Leshnower BG, Gleason PT, Chen MY, Wang DD, Tian X, Stine AM, Rogers T, Lederman RJ. Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2019 May 28;73(20):2521-2534. doi: 10.1016/j.jacc.2019.02.076.
PubMed 31118146
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
- ClinicalTrials.gov ID
- NCT03015194
- Acronym / sponsor ID
- 999917032
- Conditions
- Mitral Valve Failure
- Keywords
- LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants in this study will be among the first in the world to have this technique done.
Objectives:
To test the safety and effectiveness of the LAMPOON technique in TMVR.
Eligibility:
Adults ages 21 and over who are recommended to have TMVR with LAMPOON
Design:
Participants will be screened with medical history and exam and by review of medical records.
Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the procedure.
Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of the way before inserting the artificial mitral valve.
Participants will recover in an inpatient recovery unit.
They will repeat the previous tests before leaving the hospital, 1 month later, 6 months later and 1 year later. They will have yearly follow-up phone calls for about 5 years.
In the event of a participant's death, researchers will ask for an autopsy and to analyze the heart. Permission for this is not required as part of the study.
Detailed description
Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. For these patients the only options appear to avoid TMVR or in some to cause a focused heart attack and to wait 6 weeks. The investigators have developed and tested a technique to split the existing mitral valve leaflet and enable TMVR in patients who have no other options. The procedure is called intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices commercially available, there has been short-term success with implanted transcatheter aortic valve devices in the mitral position for TMVR.
The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options to treat their mitral valve failure, using heart valve devices designed to implant in the aortic valve position.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Experimental | Device: Edwards SAPIEN 3 transcatheter heart valve, Device: ASHI INTECC Astato XS 20The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age greater than or equal to 21 years
- Severe symptomatic native mitral valve failure after mitral annuloplasty repair or related to mitral annular calcification.
- Unacceptably high or prohibitive risk for surgical mitral valve replacement and indicated for transcatheter mitral valve replacement (TMVR) as determined by the multidisciplinary institutional heart team, including at least one cardiovascular surgeon who has examined the patient.
- High or prohibitive risk of LVOT obstruction (predicted neo-LVOT less than 200 mm2) or transcatheter heart valve dysfunction from long/redundant anterior mitral valve leaflet, as determined by the multidisciplinary institutional heart team.
- Anatomic eligibility for LAMPOON based on core lab assessment of the baseline CT and echocardiogram.
Key exclusion criteria (6 listed)
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- Predicted neo-LVOT created by the Sapien-3 skirt, after LAMPOON, less than 150 mm2
- TAVR within 6 weeks
- Intended concurrent structural heart procedure, such as aortic or tricuspid valve implantation
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 |
|---|---|---|
| Edwards SAPIEN 3 transcatheter heart valveUsed to relieve aortic stenosis in patients with symptomatic heart disease In this study it is not used for aortic stenosis-----the device is used in the mitral valve position. | Device | Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option |
| ASHI INTECC Astato XS 20The Astato 0.014" guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step. | Device | Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option |
Primary outcome
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Time frame: Exit from the Cardiac Catheterization Laboratory
Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria: * Successful LAMPOON traversal and laceration; and * Peak LVOT gradient < 50 mm Hg; and * Absence of procedural mortality; and * Successful access, delivery, and retrieval of the LAMPOON device system; and * Successful deployment and correct positioning of the first intended device; and * Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Time frame: Exit from the Cardiac Catheterization Laboratory
Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria: * Successful LAMPOON traversal and laceration; and * Peak LVOT gradient < 30 mm Hg; and * Absence of procedural mortality; and * Successful access, delivery, and retrieval of the LAMPOON device system; and * Successful deployment and correct positioning of the first intended device; and * Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39243268Khan JM, Babaliaros VC, Greenbaum AB, McCabe JM, Rogers T, Eng MH, Foerst JR, Yazdani S, Paone G, Gleason PT, Halaby RN, Bruce CG, Tian X, Stine AM, Lederman RJ. 5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2157-2167. doi: 10.1016/j.jcin.2024.05.041. Epub 2024 Sep 4.
- Derived from this study: PubMed 31118146Khan JM, Babaliaros VC, Greenbaum AB, Foerst JR, Yazdani S, McCabe JM, Paone G, Eng MH, Leshnower BG, Gleason PT, Chen MY, Wang DD, Tian X, Stine AM, Rogers T, Lederman RJ. Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2019 May 28;73(20):2521-2534. doi: 10.1016/j.jacc.2019.02.076.
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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.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards SAPIEN 3 transcatheter heart valve and ASHI INTECC Astato XS 20 in people with Mitral Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 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 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: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 29 Apr 2021). 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?
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure (time frame: Exit from the Cardiac Catheterization Laboratory). The study lists 2 primary outcomes in all. 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 NCT03015194, which also lists 2 linked publications.
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 15 Aug 2023.