Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02471807
• Collaborator: (none)
• Enrollment: 34
• Locations: 5
• Arm: 1
• Duration (Months): 85
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation	Device: Edwards FORMA Tricuspid Transcatheter Repair System	N/A

Detailed Description

The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System	Device: Edwards FORMA Tricuspid Transcatheter Repair System

Outcome Measures

Primary Outcome Measures

1. Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE [30 days]

   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.

Secondary Outcome Measures

1. Device Success : Count and Percentage of Patients Who Experienced Device Success [Intraprocedural]

   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.

2. Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success [Discharge (2-8 days)]

   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.

3. Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success [30 days]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ≥ 18 years old

2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team

Exclusion Criteria:

1. Tricuspid valve/right heart anatomy not suitable for the study device

2. Moderate or greater tricuspid valve stenosis

3. Severe RV dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Emory University Hospital	Atlanta	Georgia	United States	30322
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Morristown Medical Center	Morristown	New Jersey	United States	07960
5	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol: Rev K - Feb 8, 2018
• Study Protocol: Rev M - Feb 4, 2019
• Statistical Analysis Plan - Apr 1, 2019

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02471807
• Other Study ID Numbers: 2014-04
• First Posted: Jun 15, 2015
• Last Update Posted: Jan 6, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Period Title: Overall Study
STARTED	34
COMPLETED	11
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Overall Participants	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77 (8.20)
Sex: Female, Male (Count of Participants)
Female	22 64.7%
Male	12 35.3%
Race and Ethnicity Not Collected (Count of Participants)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	71.8 (16.49)
Height (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	1.6 (0.10)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.2 (4.20)
New York Heart Association Class (NYHA) (Count of Participants)
Class I	0 0%
Class II	6 17.6%
Class III	20 58.8%
Class IV	8 23.5%
The European System for Cardiac Operative Risk Evaluation: EuroScore II (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	7.5 (5.23)

Outcome Measures

1. Primary Outcome

Title	Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Measure Participants	34
Count of Participants [Participants]	12 35.3%

2. Secondary Outcome

Title	Device Success : Count and Percentage of Patients Who Experienced Device Success
Description	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.
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Measure Participants	34
Count of Participants [Participants]	32 94.1%

3. Secondary Outcome

Title	Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success
Description	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.
Time Frame	Discharge (2-8 days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Measure Participants	22
Count of Participants [Participants]	13 38.2%

4. Secondary Outcome

Title	Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
Description	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)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Measure Participants	25
Count of Participants [Participants]	12 35.3%

Adverse Events

Time Frame	3 years
Arm/Group Title	Edwards FORMA Tricuspid Transcatheter Repair System
Arm/Group Description	Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
All Cause Mortality
	Edwards FORMA Tricuspid Transcatheter Repair System
	Affected / at Risk (%)	# Events
Total	14/34 (41.2%)
Serious Adverse Events
	Edwards FORMA Tricuspid Transcatheter Repair System
	Affected / at Risk (%)	# Events
Total	32/34 (94.1%)
Blood and lymphatic system disorders
Anaemia	7/34 (20.6%)	7
Iron deficiency anemia	1/34 (2.9%)	1
Thrombocytopenia	1/34 (2.9%)	1
Cardiac disorders
Aortic Valve Stenosis	1/34 (2.9%)	1
Ascites	1/34 (2.9%)	1
Atrial fibrillation	2/34 (5.9%)	2
Atrial flutter	1/34 (2.9%)	1
Bradycardia	1/34 (2.9%)	1
Cardiac arrest	3/34 (8.8%)	3
Cardiac failure	12/34 (35.3%)	19
Cardiac failure acute	3/34 (8.8%)	4
Cardiac failure congestive	1/34 (2.9%)	1
Cardiac tamponade	1/34 (2.9%)	1
Cardiogenic shock	2/34 (5.9%)	2
Dyspnoea	1/34 (2.9%)	1
Left ventricular failure	2/34 (5.9%)	2
Myocardial ischaemia	1/34 (2.9%)	1
Pericardial effusion	2/34 (5.9%)	2
Pericarditis	1/34 (2.9%)	1
Right ventricular dysfunction	1/34 (2.9%)	1
Right ventricular failure	1/34 (2.9%)	1
Tricuspid valve incompetence	1/34 (2.9%)	1
Ventricular tachycardia	2/34 (5.9%)	2
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation	1/34 (2.9%)	1
Ear and labyrinth disorders
Vertigo	1/34 (2.9%)	1
Gastrointestinal disorders
Abdominal pain	1/34 (2.9%)	1
Gastritis erosive	1/34 (2.9%)	1
Gastrointestinal haemorrhage	2/34 (5.9%)	6
Gastrointestinal ulcer haemorrhage	1/34 (2.9%)	1
Intestinal perforation	1/34 (2.9%)	1
Intra-abdominal haematoma	1/34 (2.9%)	1
General disorders
Chest pain	1/34 (2.9%)	1
Death	3/34 (8.8%)	3
Device related thrombosis	1/34 (2.9%)	1
General disorders and administration site conditions	1/34 (2.9%)	1
Multiple organ dysfunction syndrome	1/34 (2.9%)	1
Oedema	1/34 (2.9%)	1
Ulcer haemorrhage	1/34 (2.9%)	1
Hepatobiliary disorders
Cholelithiasis	1/34 (2.9%)	1
Hepatic encephalopathy	2/34 (5.9%)	3
Infections and infestations
Cellulitis	2/34 (5.9%)	2
Endocarditis staphylococcal	1/34 (2.9%)	1
Escherichia bacteraemia	1/34 (2.9%)	1
Infection	2/34 (5.9%)	4
Klebsiella infection	1/34 (2.9%)	1
Lower respiratory tract infection	1/34 (2.9%)	1
Pneumonia klebsiella	1/34 (2.9%)	1
Pneumonia serratia	1/34 (2.9%)	1
Sepsis	2/34 (5.9%)	2
Septic shock	1/34 (2.9%)	1
Staphylococcal infection	1/34 (2.9%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	1/34 (2.9%)	1
Application site wound	1/34 (2.9%)	1
Arterial injury	1/34 (2.9%)	1
Cardiac perforation	2/34 (5.9%)	2
Deep vein thrombosis postoperative	1/34 (2.9%)	1
Fall	1/34 (2.9%)	1
Post procedural haematoma	1/34 (2.9%)	1
Post procedural haemorrhage	2/34 (5.9%)	2
Postoperative wound complication	1/34 (2.9%)	1
Procedural haemorrhage	2/34 (5.9%)	2
Spinal fracture	1/34 (2.9%)	1
Vascular access site haematoma	2/34 (5.9%)	2
Vascular access site haemorrhage	1/34 (2.9%)	1
Vascular pseudoaneurysm	1/34 (2.9%)	1
Investigations
International normalised ratio increase	2/34 (5.9%)	2
Occult blood positive	1/34 (2.9%)	1
Metabolism and nutrition disorders
Dehydration	1/34 (2.9%)	1
Failure to thrive	1/34 (2.9%)	1
Fluid retention	1/34 (2.9%)	1
Hyponatraemia	1/34 (2.9%)	1
Malnutrition	1/34 (2.9%)	1
Musculoskeletal and connective tissue disorders
Constochondritis	1/34 (2.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/34 (2.9%)	1
Nervous system disorders
Cerebrovascular accident	2/34 (5.9%)	2
Syncope	1/34 (2.9%)	1
Product Issues
Device dislocation	2/34 (5.9%)	2
Psychiatric disorders
Mental status changes	1/34 (2.9%)	1
Renal and urinary disorders
Acute kidney injury	3/34 (8.8%)	3
Renal failure	3/34 (8.8%)	3
Respiratory, thoracic and mediastinal disorders
Pleural effusion	4/34 (11.8%)	5
Pneumonia aspiration	1/34 (2.9%)	1
Pneumothorax	2/34 (5.9%)	2
Respiratory Failure	2/34 (5.9%)	2
Surgical and medical procedures
Cardiac resynchronisation therapy	1/34 (2.9%)	1
Glaucoma surgery	1/34 (2.9%)	1
Hip arthroplasty	1/34 (2.9%)	1
Vascular disorders
Arteriovenous fistula	1/34 (2.9%)	1
Epistaxis	1/34 (2.9%)	2
Gastrointestinal haemorrhage	1/34 (2.9%)	1
Haemorrhage	2/34 (5.9%)	2
Hypotension	4/34 (11.8%)	4
Internal haemorrhage	1/34 (2.9%)	1
Pulmonary embolism	1/34 (2.9%)	1
Rectal haemorrhage	1/34 (2.9%)	1
Shock haemorrhagic	1/34 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Edwards FORMA Tricuspid Transcatheter Repair System
	Affected / at Risk (%)	# Events
Total	32/34 (94.1%)
Blood and lymphatic system disorders
Anaemia	6/34 (17.6%)	6
Thrombocytopenia	3/34 (8.8%)	3
Cardiac disorders
Ascites	3/34 (8.8%)	3
Atrial fibrillation	2/34 (5.9%)	2
Bundle branch block right	3/34 (8.8%)	3
Cardiac failure	5/34 (14.7%)	5
Pericardial effusion	3/34 (8.8%)	3
Ventricular tachycardia	4/34 (11.8%)	4
Gastrointestinal disorders
Vomiting	2/34 (5.9%)	2
Injury, poisoning and procedural complications
Fall	2/34 (5.9%)	2
Investigations
Myocardial necrosis marker increased	2/34 (5.9%)	2
Troponin increased	2/34 (5.9%)	2
Metabolism and nutrition disorders
Hypokalaemia	2/34 (5.9%)	2
Renal and urinary disorders
Acute kidney injury	3/34 (8.8%)	5
Haematuria	2/34 (5.9%)	3
Urinary retention	3/34 (8.8%)	4
Renal failure	6/34 (17.6%)	6
Respiratory, thoracic and mediastinal disorders
Pleural effusion	3/34 (8.8%)	5
Vascular disorders
Hypotension	4/34 (11.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.