Back to resultsThe SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System (SPACER)
Primary Purpose
Tricuspid Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EW Tricuspid Transcatheter Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Valve Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
- Eighteen years of age or older
- Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
- Functional tricuspid regurgitation as the primary etiology
- New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
- Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device
- Willing to attend study follow-up assessments for up to 3 years
Exclusion Criteria
Tricuspid valve/right heart anatomy not suitable for the study device:
- Native tricuspid annulus area < 2.14 cm2 (9 mm device) or < 2.63 cm2 (12 mm device) or < 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
- Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
- Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)
- Moderate or greater tricuspid valve stenosis
- Untreated clinically significant coronary artery disease requiring immediate revascularization
- Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
- Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure
- Myocardial infarction within 30 days of scheduled implant procedure
- Hemodynamic instability within 30 days of scheduled implant procedure
- Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
- Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure
- Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
- Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
- Active endocarditis or infection within 3 months of scheduled implant procedure
- Cerebrovascular accident within 3 months of scheduled implant procedure
- Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
- Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
- Evidence of right sided intracardiac mass, thrombus, or vegetation
- Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
- Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
- Known hypersensitivity to cobalt chromium, nitinol or titanium
- Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
- Patient is a current intravenous drug user
- Female of child-bearing potential is pregnant or lactating
- Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
- Patient requires emergent/emergency treatment for tricuspid insufficiency
- Patient is under guardianship
Sites / Locations
- St. Paul's Hospital, Providence Health Care Research Institute
- Toronto General Hospital
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval
- Institut Hospitalier Jacques Cartier
- Hōpital Charles Nicolle
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
- Charite-Universitätsmedzin Berlin
- Asklepios Klinik St. Georg
- Munich University Clinic, Ludwig-Maximilian University
- Hygeia Hospital
- Inselspital, Universitätsspital Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EW Tricuspid Transcatheter Repair System
Arm Description
Edwards (EW) Tricuspid Transcatheter Repair System
Outcomes
Primary Outcome Measures
All-cause Mortality
The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.
Secondary Outcome Measures
Technical Success
Alive, with
Successful access, delivery and removal of the delivery systems, and
Deployment and correct positioning of the intended device, and
No need for additional emergency surgery or re-intervention related to the device or access procedure
Device Success
Alive, with
Original intended device in place, and
No additional surgical or interventional procedures related to the device, and
Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg
Procedural Success
Device Success, and
None of the following device or procedure related Serious Adverse Events (SAE):
Life threatening bleeding
Major vascular or cardiac structural complications requiring intervention
Pericardial effusion requiring drainage or surgery (includes tamponade)
Stage 2 or 3 acute kidney injury (includes new dialysis).
Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support
Prolonged intubation > 48 hours
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
Re-hospitalization rates for the underlying condition (heart failure)
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
Re-intervention rates for the underlying condition (tricuspid regurgitation)
Clinical Outcomes [Changes in Peripheral Edema]
Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Change in New York Heart Association (NYHA) Class compared to baseline
Measure Description:
Measure Description: NYHA Classification - The stages of heart failure:
Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest.
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Change in 6 minute walk test distance (meters) compared to baseline
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02787408
Brief Title
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Acronym
SPACER
Official Title
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
December 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.
Detailed Description
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EW Tricuspid Transcatheter Repair System
Arm Type
Experimental
Arm Description
Edwards (EW) Tricuspid Transcatheter Repair System
Intervention Type
Device
Intervention Name(s)
EW Tricuspid Transcatheter Repair System
Intervention Description
Treatment with the EW Tricuspid Transcatheter Repair System
Primary Outcome Measure Information:
Title
All-cause Mortality
Description
The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.
Time Frame
At 30 days.
Secondary Outcome Measure Information:
Title
Technical Success
Description
Alive, with
Successful access, delivery and removal of the delivery systems, and
Deployment and correct positioning of the intended device, and
No need for additional emergency surgery or re-intervention related to the device or access procedure
Time Frame
Implant Procedure
Title
Device Success
Description
Alive, with
Original intended device in place, and
No additional surgical or interventional procedures related to the device, and
Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg
Time Frame
At 1 month, 6 months, 1, 2, and 3 years
Title
Procedural Success
Description
Device Success, and
None of the following device or procedure related Serious Adverse Events (SAE):
Life threatening bleeding
Major vascular or cardiac structural complications requiring intervention
Pericardial effusion requiring drainage or surgery (includes tamponade)
Stage 2 or 3 acute kidney injury (includes new dialysis).
Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support
Prolonged intubation > 48 hours
Time Frame
At 1 month
Title
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
Description
Re-hospitalization rates for the underlying condition (heart failure)
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
Description
Re-intervention rates for the underlying condition (tricuspid regurgitation)
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Changes in Peripheral Edema]
Description
Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Description
Change in New York Heart Association (NYHA) Class compared to baseline
Measure Description:
Measure Description: NYHA Classification - The stages of heart failure:
Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest.
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Description
Change in 6 minute walk test distance (meters) compared to baseline
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Description
Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
Title
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Description
Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time Frame
At 1 month, 6 months, 1, 2 and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
Eighteen years of age or older
Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
Functional tricuspid regurgitation as the primary etiology
New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device
Willing to attend study follow-up assessments for up to 3 years
Exclusion Criteria
Tricuspid valve/right heart anatomy not suitable for the study device:
Native tricuspid annulus area < 2.14 cm2 (9 mm device) or < 2.63 cm2 (12 mm device) or < 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)
Moderate or greater tricuspid valve stenosis
Untreated clinically significant coronary artery disease requiring immediate revascularization
Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure
Myocardial infarction within 30 days of scheduled implant procedure
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure
Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
Active endocarditis or infection within 3 months of scheduled implant procedure
Cerebrovascular accident within 3 months of scheduled implant procedure
Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
Evidence of right sided intracardiac mass, thrombus, or vegetation
Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
Known hypersensitivity to cobalt chromium, nitinol or titanium
Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
Patient is a current intravenous drug user
Female of child-bearing potential is pregnant or lactating
Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
Patient requires emergent/emergency treatment for tricuspid insufficiency
Patient is under guardianship
Facility Information:
Facility Name
St. Paul's Hospital, Providence Health Care Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Hōpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Charite-Universitätsmedzin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Munich University Clinic, Ludwig-Maximilian University
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Hygeia Hospital
City
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
Inselspital, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
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