Trial Outcomes & Findings for Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System (NCT NCT02471807)
NCT ID: NCT02471807
Last Updated: 2023-03-28
Results Overview
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention for study device related complications or on the previously implanted study device, and major access site and vascular complications requiring intervention at 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
30 days
Results posted on
2023-03-28
Participant Flow
Participant milestones
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Overall Study
Death
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Explant
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=34 Participants
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Age, Continuous
|
77 years
STANDARD_DEVIATION 8.20 • n=34 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=34 Participants
|
|
BMI
|
26.2 kg/m^2
STANDARD_DEVIATION 4.20 • n=34 Participants
|
|
New York Heart Association Class (NYHA)
Class I
|
0 Participants
n=34 Participants
|
|
New York Heart Association Class (NYHA)
Class II
|
6 Participants
n=34 Participants
|
|
New York Heart Association Class (NYHA)
Class III
|
20 Participants
n=34 Participants
|
|
New York Heart Association Class (NYHA)
Class IV
|
8 Participants
n=34 Participants
|
|
The European System for Cardiac Operative Risk Evaluation: EuroScore II
|
7.5 score
STANDARD_DEVIATION 5.23 • n=34 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The intention-to-treat (ITT) population includes all patients who signed informed consent, met eligibility criteria, and in whom the study procedure has been attempted (i.e. at least skin incision to introduce the FORMA System).
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention for study device related complications or on the previously implanted study device, and major access site and vascular complications requiring intervention at 30 days.
Outcome measures
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=34 Participants
Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
|
10 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: The intention-to-treat (ITT) population includes all patients who signed informed consent, met eligibility criteria, and in whom the study procedure has been attempted (i.e. at least skin incision to introduce the FORMA System).
Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Outcome measures
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=34 Participants
Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Device Success : Count and Percentage of Patients Who Experienced Device Success
|
32 Participants
|
SECONDARY outcome
Timeframe: Discharge (2-8 days)Population: The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.
Device success with evidence of TR reduction as evidenced by a relative reduction in EROA of ≥ 30% from baseline to discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge.
Outcome measures
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=23 Participants
Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success
|
12 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.
Procedural success without MAEs at 30 days. (MAEs: cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention and major access site and vascular complications)
Outcome measures
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=26 Participants
Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
|
11 Participants
|
Adverse Events
Edwards FORMA Tricuspid Transcatheter Repair System
Serious events: 33 serious events
Other events: 32 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=34 participants at risk
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.6%
7/34 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Aortic Valve Stenosis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Ascites
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Atrial flutter
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Bradycardia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac arrest
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
38.2%
13/34 • Number of events 23 • 3 years
|
|
Cardiac disorders
Cardiac failure acute
|
8.8%
3/34 • Number of events 4 • 3 years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac tamponade
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiogenic shock
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Left ventricular failure
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Myocardial ischaemia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Pericarditis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Right ventricular dysfunction
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Right ventricular failure
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
8.8%
3/34 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Death
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
General disorders
Device related thrombosis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
General disorders and administration site conditions
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Oedema
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Ulcer haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
5.9%
2/34 • Number of events 3 • 3 years
|
|
Infections and infestations
Cellulitis
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Infections and infestations
Endocarditis staphylococcal
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Escherichia bacteraemia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection
|
5.9%
2/34 • Number of events 4 • 3 years
|
|
Infections and infestations
Klebsiella infection
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia klebsiella
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia serratia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Infections and infestations
Septic shock
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Infections and infestations
Staphylococcal infection
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Application site wound
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Arterial injury
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Cardiac perforation
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Investigations
International normalised ratio increase
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Investigations
Occult blood positive
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Constochondritis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Product Issues
Device dislocation
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Mental status changes
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Renal failure
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
4/34 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Glaucoma surgery
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Arteriovenous fistula
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Epistaxis
|
2.9%
1/34 • Number of events 2 • 3 years
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Haemorrhage
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypotension
|
11.8%
4/34 • Number of events 4 • 3 years
|
|
Vascular disorders
Internal haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Pulmonary embolism
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Rectal haemorrhage
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Vascular disorders
Shock haemorrhagic
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Acute left ventricular failure
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiorenal syndrome
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural hypotention
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
2.9%
1/34 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Edwards FORMA Tricuspid Transcatheter Repair System
n=34 participants at risk
Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.6%
7/34 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Ascites
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Cardiac disorders
Bundle branch block right
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
17.6%
6/34 • Number of events 6 • 3 years
|
|
Cardiac disorders
Pericardial effusion
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
11.8%
4/34 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Investigations
Myocardial necrosis marker increased
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Investigations
Troponin increased
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
2/34 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
8.8%
3/34 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Haematuria
|
5.9%
2/34 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
11.8%
4/34 • Number of events 5 • 3 years
|
|
Vascular disorders
Hypotension
|
11.8%
4/34 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Renal failure
|
17.6%
6/34 • Number of events 6 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.8%
3/34 • Number of events 5 • 3 years
|
|
Infections and infestations
Genitourinary tract infections and inflammation NEC
|
8.8%
3/34 • Number of events 3 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Number of events 2 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place