TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03227757
• Collaborator: (none)
• Enrollment: 85
• Locations: 20
• Arm: 1
• Anticipated Duration (Months): 82.3
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Insufficiency	Device: Tricuspid Valve Repair System	N/A

Detailed Description

This is a prospective, single arm, multi-center study.

A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Nov 14, 2019
• Anticipated Study Completion Date: Jun 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tricuspid Valve Repair System Subjects who received TVRS will be included in this arm.	Device: Tricuspid Valve Repair System; Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [At 30 days]

   Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.

2. Number of Participants With Composite of Major Adverse Event (MAE) [At 6 months]

   Major Adverse Event (MAE) is defined as a composite of: Cardiovascular Mortality Myocardial Infarction (MI) Stroke New onset renal failure Endocarditis requiring surgery, and Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.

2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.

3. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

4. In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated.

5. New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV

6. Subjects with moderate TR: Only NYHA Class III or IV may be considered

7. Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion

8. No indication for left-sided or pulmonary valve correction.

9. The Site Heart Team concur the benefit-risk analysis supports intervention for tricuspid regurgitation per current guidelines for the management of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.

10. In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.

Echocardiographic Inclusion Criteria:

1. Moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) confirmed by the Echocardiography Core Lab (ECL).

2. Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team.

3. Tricuspid valve anatomy evaluable by TTE and TEE.

Exclusion Criteria:

1. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

2. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

3. Severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg).

4. Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined).

5. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.

6. Mitral Regurgitation moderate-severe or greater severity (≥3+).

7. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.

8. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.

9. Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.

10. Percutaneous coronary intervention within prior 30 days prior to enrollment.

11. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.

12. Cerebrovascular Accident (CVA) within prior 3 months to enrollment.

13. Chronic dialysis.

14. Bleeding disorders or hypercoagulable state.

15. Active peptic ulcer or active gastrointestinal (GI) bleeding.

16. Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.

17. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection).

18. Known allergy or hypersensitivity to device materials.

19. In the judgement of the investigator, a condition that could limit a patient's ability or unwillingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.

20. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.

21. Life expectancy of less than 12 months due to non-cardiac conditions.

Echocardiographic Exclusion Criteria:

1. Tricuspid stenosis.

2. Left Ventricular Ejection Fraction (LVEF) ≤20%.

3. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:

4. Evidence of calcification in the grasping area

5. Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Henry Ford Hospital	Detroit	Michigan	United States	48202
3	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
4	Mount Sinai Hospital	New York	New York	United States	10029
5	Hospital Nord Laennec - Chu De Nantes	Nantes	Saint-Herblain	France	44 093
6	Bichat-Claude Bernard Hospital	Paris		France	75018
7	Ludwig-Maximilian University of Munich (LMU)	Munich	Bavaria	Germany	81377
8	Schuchtermann Klinik	Bad Rothenfelde	Lower Saxony	Germany	49214
9	University Hospital Bonn	Bonn	North Rhine-Westphalia	Germany	53127
10	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz	Rhineland-Palatinate	Germany	55131
11	Leipzig Heart Center	Leipzig	Saxony	Germany	04289
12	Albertinen-Krankenhaus	Hamburg		Germany	22457
13	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto	Catania	Catania (CT)	Italy	95124
14	San Raffaele University Hospital	Milano	Milan	Italy	20132
15	Istituto Clinico Sant'Ambrogio	Milano	Milan	Italy	20149
16	Hospital de Sant Pau	Barcelona		Spain	08025
17	Clinical and Provincial Hospital of Barcelona	Barcelona		Spain	08036
18	Inselspital Bern	Bern		Switzerland	3010
19	HerzKlinik Hirslanden - Klinik Hirslanden	Zurich		Switzerland	8032
20	University Hospital of Zurich (USZ)	Zurich		Switzerland	8091

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Prof. Georg Nickenig, University Hospital, Bonn

Study Documents (Full-Text)

• Study Protocol - Feb 1, 2018
• Statistical Analysis Plan - Aug 16, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03227757
• Other Study ID Numbers: 16-517
• First Posted: Jul 24, 2017
• Last Update Posted: Dec 23, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Abbott Medical Devices: TRILUMINATE; Percutaneous transcatheter intervention; Tricuspid regurgitation; Tricuspid Valve Repair System
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	A total of 85 subjects were enrolled and underwent Tricuspid Valve Repair System (TVRS) procedure.

Arm/Group Title	Tricuspid Valve Repair System
Arm/Group Description	Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Period Title: Overall Study
STARTED	85
COMPLETED	69
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Tricuspid Valve Repair System
Arm/Group Description	Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Overall Participants	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.8 (7.9)
Sex: Female, Male (Count of Participants)
Female	56 65.9%
Male	29 34.1%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	4 4.7%
Unknown or Not Reported	54 63.5%
Region of Enrollment (Count of Participants)
United States	12 14.1%
France	2 2.4%
Germany	45 52.9%
Italy	11 12.9%
Spain	8 9.4%
Switzerland	7 8.2%
New York Heart Association (NYHA) class II or above (Count of Participants)
NYHA class II	21 24.7%
NYHA class III	58 68.2%
NYHA class IV	4 4.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Description	Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Time Frame	At 30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Tricuspid Valve Repair System
Arm/Group Description	Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Measure Participants	83
Count of Participants [Participants]	71 83.5%

2. Primary Outcome

Title	Number of Participants With Composite of Major Adverse Event (MAE)
Description	Major Adverse Event (MAE) is defined as a composite of: Cardiovascular Mortality Myocardial Infarction (MI) Stroke New onset renal failure Endocarditis requiring surgery, and Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Tricuspid Valve Repair System
Arm/Group Description	Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Measure Participants	84
Count of Participants [Participants]	5 5.9%

Adverse Events

Time Frame	1 year
Arm/Group Title	Tricuspid Valve Repair System
Arm/Group Description	Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
All Cause Mortality
	Tricuspid Valve Repair System
	Affected / at Risk (%)	# Events
Total	7/85 (8.2%)
Serious Adverse Events
	Tricuspid Valve Repair System
	Affected / at Risk (%)	# Events
Total	44/85 (51.8%)
Cardiac disorders
Angina pectoris	1/85 (1.2%)
Atrial fibrillation	3/85 (3.5%)
Atrial flutter	3/85 (3.5%)
Cardiac failure	10/85 (11.8%)
Cardiorenal syndrome	1/85 (1.2%)
Left ventricular dysfunction	1/85 (1.2%)
Sick sinus syndrome	1/85 (1.2%)
Tricuspid valve incompetence	1/85 (1.2%)
Ear and labyrinth disorders
Vertigo	1/85 (1.2%)
Eye disorders
Cataract	1/85 (1.2%)
Glaucoma	1/85 (1.2%)
Gastrointestinal disorders
Dysphagia	1/85 (1.2%)
Gastritis haemorrhagic	1/85 (1.2%)
Gastrointestinal haemorrhage	1/85 (1.2%)
Intestinal haemorrhage	1/85 (1.2%)
Oesophagitis ulcerative	1/85 (1.2%)
General disorders
Chest pain	1/85 (1.2%)
Death	1/85 (1.2%)
Medical device complication	1/85 (1.2%)
Multi-organ failure	1/85 (1.2%)
Infections and infestations
Bronchopneumonia	1/85 (1.2%)
Gallbladder empyema	1/85 (1.2%)
Pneumonia	4/85 (4.7%)
Urinary tract infection	2/85 (2.4%)
Injury, poisoning and procedural complications
Femur fracture	1/85 (1.2%)
Humerus fracture	1/85 (1.2%)
Upper limb fracture	1/85 (1.2%)
Vascular pseudoaneurysm	1/85 (1.2%)
Investigations
Blood sodium decreased	1/85 (1.2%)
Ejection fraction decreased	1/85 (1.2%)
Haemoglobin decreased	2/85 (2.4%)
Metabolism and nutrition disorders
Failure to thrive	1/85 (1.2%)
Hyperglycaemia	1/85 (1.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/85 (1.2%)
Osteoarthritis	2/85 (2.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/85 (1.2%)
Nervous system disorders
Burning sensation	1/85 (1.2%)
Syncope	1/85 (1.2%)
Psychiatric disorders
Anxiety	1/85 (1.2%)
Renal and urinary disorders
Renal failure	5/85 (5.9%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/85 (1.2%)
Dyspnoea	2/85 (2.4%)
Hypoxia	1/85 (1.2%)
Pleural effusion	1/85 (1.2%)
Pulmonary embolism	1/85 (1.2%)
Pulmonary oedema	1/85 (1.2%)
Vascular disorders
Arterial occlusive disease	1/85 (1.2%)
Arteriovenous fistula	1/85 (1.2%)
Deep vein thrombosis	2/85 (2.4%)
Femoral arterial stenosis	1/85 (1.2%)
Haemorrhage	12/85 (14.1%)
Hypertension	1/85 (1.2%)
Hypertensive crisis	1/85 (1.2%)
Hypotension	2/85 (2.4%)
Other (Not Including Serious) Adverse Events
	Tricuspid Valve Repair System
	Affected / at Risk (%)	# Events
Total	39/85 (45.9%)
Cardiac disorders
Atrial fibrillation	6/85 (7.1%)
Cardiac failure	12/85 (14.1%)
Infections and infestations
Urinary tract infection	5/85 (5.9%)
Renal and urinary disorders
Renal failure	9/85 (10.6%)
Vascular disorders
Haemorrhage	22/85 (25.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.