Trial Outcomes & Findings for NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study (NCT NCT03929913)

Last Updated: 2024-12-04

Results Overview

The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present: 1. Alive 2. Successful deployment and correct positioning of a single intended Transcatheter Mitral Cerclage Annuloplasty (TMCA). Repositioning and recapture of the device, if needed, is not classified as failure. 3. Retrieval of the TMCA delivery system 4. Absence of TMCA-related coronary artery compression and absence of additional procedure such as percutaneous coronary intervention (PCI) to relieve coronary artery compression. 5. No additional unplanned or emergency surgery or re-intervention related to the TMCA or delivery system.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

19 participants

Primary outcome timeframe

1 minute following procedure discharge (Exit from the catheterization laboratory)

Results posted on

2024-12-04

Participant Flow

Nineteen subjects consented and underwent cerclage procedures between May 2019 and February 2021, despite COVID-19-related delays.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	19
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	4
Overall Study Lost to Follow-up	1
Overall Study Failed Procedure	2

Baseline Characteristics

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcatheter Mitral Valve Cerclage Annuloplasty n=19 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Heart failure with reduced ejection fraction (HFrEF)	12 Participants n=5 Participants
Heart failure with preserved ejection fraction (HFpEF)	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Cerclage Annuloplasty n=19 Participants 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.
The Primary Endpoint is Technical Success	17 Participants

SECONDARY outcome

Timeframe: Day 30 post procedure

The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present: 1. Technical success 2. No Transcatheter Mitral Cerclage Annuloplasty (TMCA) device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TMCA requiring unplanned reintervention or surgery.

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Cerclage Annuloplasty n=19 Participants 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.
The Secondary Endpoint is Procedural Success	16 Participants

Adverse Events

Transcatheter Mitral Valve Cerclage Annuloplasty

Serious events: 12 serious events

Other events: 19 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Transcatheter Mitral Valve Cerclage Annuloplasty n=19 participants at risk 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.
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Number of events 1 • 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.
Renal and urinary disorders Acute kidney injury	10.5% 2/19 • Number of events 2 • 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.
Blood and lymphatic system disorders Anemia	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Atrial fibrillation	10.5% 2/19 • Number of events 4 • 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.
Cardiac disorders Atrioventricular block complete	21.1% 4/19 • Number of events 4 • 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.
Cardiac disorders Cardiac arrest	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Cardiogenic Shock-post cardiac arrest	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Torsade de Pointes	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Cardiac Chest pain	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Heart failure	36.8% 7/19 • Number of events 18 • 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.
Cardiac disorders Myocardial infarction	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Sinus bradycardia	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Supraventricular tachycardia	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Ventricular fibrillation	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchospasm	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	5.3% 1/19 • Number of events 1 • 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.
Psychiatric disorders Confusion	5.3% 1/19 • Number of events 1 • 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.
Nervous system disorders Encephalopathy	10.5% 2/19 • Number of events 3 • 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.
Nervous system disorders Stroke	5.3% 1/19 • Number of events 1 • 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.
Nervous system disorders Syncope	5.3% 1/19 • Number of events 1 • 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.
Nervous system disorders Transient ischemic attacks	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Hemoperitoneum with suspected clot overlaying left anterior liver left lobe	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Transaminitis-Shock liver post cardiac arrest-elevated liver enzymes; moderate ascites on US.	5.3% 1/19 • Number of events 1 • 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.
Infections and infestations Hepatitis viral	5.3% 1/19 • Number of events 1 • 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.
Infections and infestations COVID infection, hospitalized. Unvaccinated	5.3% 1/19 • Number of events 1 • 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.
Vascular disorders Hypotension	15.8% 3/19 • Number of events 3 • 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.
Investigations Sodium low	5.3% 1/19 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer diagnosis	5.3% 1/19 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Transcatheter Mitral Valve Cerclage Annuloplasty n=19 participants at risk 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.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • 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.
Renal and urinary disorders Chronic kidney disease	5.3% 1/19 • Number of events 1 • 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.
Renal and urinary disorders Hematuria	5.3% 1/19 • Number of events 1 • 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.
Renal and urinary disorders Urinary retention	5.3% 1/19 • Number of events 1 • 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.
Blood and lymphatic system disorders Anemia	47.4% 9/19 • Number of events 9 • 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.
Blood and lymphatic system disorders Leukocytosis	68.4% 13/19 • Number of events 13 • 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.
Respiratory, thoracic and mediastinal disorders Atelectasis	10.5% 2/19 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.5% 2/19 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	5.3% 1/19 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Inflammatory Lung nodule	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Atrial fibrillation	10.5% 2/19 • Number of events 2 • 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.
Cardiac disorders Atrioventricular block complete	10.5% 2/19 • Number of events 2 • 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.
Cardiac disorders Atrioventricular block first degree	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Episode of PAF during procedure requiring cardioversion	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Cardiac troponin I increased	100.0% 19/19 • Number of events 19 • 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.
Cardiac disorders Cardiac Chest pain	10.5% 2/19 • Number of events 2 • 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.
Cardiac disorders Conduction disorder	26.3% 5/19 • Number of events 5 • 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.
Cardiac disorders Heart failure	31.6% 6/19 • Number of events 6 • 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.
Cardiac disorders Pericardial effusion	10.5% 2/19 • Number of events 2 • 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.
Cardiac disorders Sinus tachycardia	5.3% 1/19 • Number of events 1 • 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.
Cardiac disorders Tricuspid valve disease	10.5% 2/19 • Number of events 2 • 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.
Investigations Cardiac troponin I increased	100.0% 19/19 • Number of events 19 • 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.
Investigations Creatinine increased	26.3% 5/19 • Number of events 5 • 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.
Investigations Ejection fraction decreased	10.5% 2/19 • Number of events 2 • 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.
Investigations BNP elevated post procedure	26.3% 5/19 • Number of events 5 • 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.
Investigations NT-BNP elevated post procedure	21.1% 4/19 • Number of events 4 • 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.
Investigations Elevated PCWP-post procedure from baseline	5.3% 1/19 • Number of events 1 • 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.
Investigations Platelet count decreased	42.1% 8/19 • Number of events 8 • 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.
Musculoskeletal and connective tissue disorders Chest wall pain	10.5% 2/19 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.3% 1/19 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Neck pain	5.3% 1/19 • Number of events 1 • 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.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • 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.
Gastrointestinal disorders Dysphagia	5.3% 1/19 • Number of events 1 • 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.
General disorders Edema limbs	5.3% 1/19 • Number of events 1 • 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.
General disorders Generalized itching post procedure	5.3% 1/19 • Number of events 1 • 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.
General disorders Pain	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Compression of left anterior descending artery	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Air embolization	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Cerclage device created compression of the LAD during cinching of the device.	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Crimp failure after tension element successfully traversed myocardium	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Cutter Device malfunction	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Throat pain and tongue swelling	5.3% 1/19 • Number of events 1 • 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.
Injury, poisoning and procedural complications Vascular access complication	5.3% 1/19 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the right lower lobe lung	5.3% 1/19 • Number of events 1 • 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.

Additional Information

Dr. Robert Lederman, Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Phone: 301.402.6769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER