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| ID | Type | Description | Link |
|---|---|---|---|
| 19-H-0088 |
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This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as "cerclage". Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage. This leakage causes heart failure (breathlessness and lack of energy especially when walking or exercising, and hospital admissions for fluid buildup).
This is an early feasibility study (EFS) evaluation of special devices, permanently implanted in the heart, to perform mitral cerclage annuloplasty. Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage devices compress the mitral valve like a purse-string. The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string.
The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment, and to allow patients who have symptomatic heart failure with mild mitral regurgitation.
Functional mitral regurgitation (also known as secondary mitral regurgitation) is a common complication of left ventricular dysfunction. Ventricular dysfunction leads to dilation, which in turn leads to mitral annular dilation and leaflet traction. This causes a failure of coaptation of the otherwise intact leaflets of the mitral valve, leading to regurgitation through a central orifice between the mal-coapting leaflet tips. Functional mitral regurgitation contributes to heart failure symptoms. Transcatheter Mitral Cerclage Annuloplasty (TMCA) is a new catheter technique that reduces the septal-lateral dimension of the dilated annulus through circumferential compression, prevents extrinsic compression and entrapment of coronary arteries by incorporating a protection element, and exhibits planar discordance that achieves annular reduction even when the coronary sinus is anatomically located along the posterior left atrial wall. This is an entirely right-sided procedure and device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Mitral Valve Cerclage Annuloplasty | Experimental | To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) | Device | The Transcatheter Mitral Cerclage Annuloplasty implant has two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and right ventricular outflow track limbs. Procedure is performed from a trans-jugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein to the target capture catheter. The implant is then attached to the back end of the guidewire and pulled out of the internal jugular sheath. The position of the implant is adjusted so the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is advanced over the two limbs of the implant and the desired tension is titrated to the degree of mitral regurgitation. Coronary angiography is performed to confirm there is no coronary compression. After desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is Technical Success | The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:
| 1 minute following procedure discharge (Exit from the catheterization laboratory) |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Endpoint is Procedural Success | The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present:
|
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INCLUSION CRITERIA:
Adults age >=21 years
Symptomatic functional mitral valve regurgitation
On optimal medical therapy for at least one month
Left ventricular ejection fraction >=0.20 assessed by echocardiography, CT, or CMR
Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
Concordance of the Study Eligibility Committee
If present, a MitraClip was implanted at least 30 days previously
EXCLUSION CRITERIA:
Subjects unable to consent to participate
Subjects unwilling to participate or unwilling to return for study follow-up activities.
Prior cardiac implanted electronic devices (CIED) likely to be entrapped by cerclage.
-- Candidates with coronary sinus or left ventricular pacing or defibrillation leads that are not likely to be entrapped by cerclage, evident on baseline CT or angiogram, are eligible to participate.
TAVR within 6 weeks
Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
Aortic stenosis more than mild in severity
Single-leaflet MitraClip detachment, if present
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Emory University |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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The authors are willing to share de-identified subject data upon reasonable request.
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Nineteen subjects consented and underwent cerclage procedures between May 2019 and February 2021, despite COVID-19-related delays.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcatheter Mitral Valve Cerclage Annuloplasty | To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcatheter Mitral Valve Cerclage Annuloplasty | To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint is Technical Success | The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:
| Posted | Count of Participants | Participants | 1 minute following procedure discharge (Exit from the catheterization laboratory) |
|
5 years
Adverse event recording starts on Day (0) of the Transcatheter Mitral Cerclage Annuloplasty procedure and continues through the 12 month Follow Up. Reporting of serious adverse events (SAE) and serious adverse device effects (SADE) will continue at annual visits thereafter to year 5. Once the subject's 30 day follow up is completed, only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcatheter Mitral Valve Cerclage Annuloplasty | To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Lederman, Principal Investigator | National Heart, Lung, and Blood Institute (NHLBI) | 301.402.6769 | ledermar@nhlbi.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2021 | Feb 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2021 | Feb 9, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Day 30 post procedure |
| Atlanta |
| Georgia |
| 30322-1102 |
| United States |
| Carilion Medical Center | Roanoke | Virginia | 24014 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Heart failure with reduced ejection fraction (HFrEF) | Count of Participants | Participants |
|
| Heart failure with preserved ejection fraction (HFpEF) | Count of Participants | Participants |
|
|
|
| Secondary | The Secondary Endpoint is Procedural Success | The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present:
| Posted | Count of Participants | Participants | Day 30 post procedure |
|
|
|
| 5 |
| 19 |
| 12 |
| 19 |
| 19 |
| 19 |
| Acute kidney injury | Renal and urinary disorders | CTCAE | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiogenic Shock-post cardiac arrest | Cardiac disorders | CTCAE | Systematic Assessment |
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| Torsade de Pointes | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiac Chest pain | Cardiac disorders | CTCAE | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | CTCAE | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | CTCAE | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | CTCAE | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | CTCAE | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE | Systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE | Systematic Assessment |
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| Transient ischemic attacks | Nervous system disorders | CTCAE | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
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| Hemoperitoneum with suspected clot overlaying left anterior liver left lobe | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment | hemoperitoneum with suspected clot overlaying left anterior liver left lobe post cardiac compressions with cardiac arrest response. |
|
| Transaminitis-Shock liver post cardiac arrest-elevated liver enzymes; moderate ascites on US. | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
|
| Hepatitis viral | Infections and infestations | CTCAE | Systematic Assessment |
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| COVID infection, hospitalized. Unvaccinated | Infections and infestations | CTCAE | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE | Systematic Assessment |
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| Sodium low | Investigations | CTCAE | Systematic Assessment |
|
| Colon cancer diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | CTCAE | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Inflammatory Lung nodule | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | CTCAE | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | CTCAE | Systematic Assessment |
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| Episode of PAF during procedure requiring cardioversion | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiac troponin I increased | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiac Chest pain | Cardiac disorders | CTCAE | Systematic Assessment |
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| Conduction disorder | Cardiac disorders | CTCAE | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | CTCAE | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE | Systematic Assessment |
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| Tricuspid valve disease | Cardiac disorders | CTCAE | Systematic Assessment |
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| Cardiac troponin I increased | Investigations | CTCAE | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE | Systematic Assessment |
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| Ejection fraction decreased | Investigations | CTCAE | Systematic Assessment |
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| BNP elevated post procedure | Investigations | CTCAE | Systematic Assessment |
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| NT-BNP elevated post procedure | Investigations | CTCAE | Systematic Assessment |
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| Elevated PCWP-post procedure from baseline | Investigations | CTCAE | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE | Systematic Assessment |
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| Generalized itching post procedure | General disorders | CTCAE | Systematic Assessment |
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| Pain | General disorders | CTCAE | Systematic Assessment |
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| Compression of left anterior descending artery | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment | Aborted implantation of cerclage device RT device causing compression of left anterior descending artery |
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| Air embolization | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
|
| Cerclage device created compression of the LAD during cinching of the device. | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
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| Crimp failure after tension element successfully traversed myocardium | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment | Crimp failure after tension element successfully traversed myocardium, during withdrawal from Gore Sheath. |
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| Cutter Device malfunction | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
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| Throat pain and tongue swelling | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
|
| Adenocarcinoma of the right lower lobe lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Systematic Assessment |
|
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A Publications Committee comprised of the NIH Principal Investigator (PI) and Investigators participating in the study, as appropriate, will be formed to oversee the publication and presentation of the study results, which will reflect the experience of all investigational sites. No publication or disclosure of study results will be permitted except under the terms and conditions of a separate written agreement between NIH PI and the non-NIH Investigator and/or the Investigator's institution.