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Tricuspid Valve RegurgitationSPACERNCT02787408

The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

A study testing EW Tricuspid Transcatheter Repair System in people with Tricuspid Valve Regurgitation, run by Edwards Lifesciences at 11 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Valve Regurgitation
What is being tested?
EW Tricuspid Transcatheter Repair System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
11 sitesin 5 countries
Study dates
14 Sep 2016to 14 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

Germany4 sites

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189

  • Charite-Universitätsmedzin Berlin

    Berlin, 10117

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Munich University Clinic, Ludwig-Maximilian University

    Munich, 81377

Other trials in Germany

Canada3 sites

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval

    Québec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • St. Paul's Hospital, Providence Health Care Research Institute

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

France2 sites

  • Institut Hospitalier Jacques Cartier

    Massy, 91300

  • Hōpital Charles Nicolle

    Rouen, 76031

Other trials in France

Greece1 site

  • Hygeia Hospital

    Athens, 15123

Other trials in Greece

Switzerland1 site

  • Inselspital, Universitätsspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
EW Tricuspid Transcatheter Repair System
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EW Tricuspid Transcatheter Repair SystemDevice

    Treatment with the EW Tricuspid Transcatheter Repair System

Study groups in NCT02787408
Study groupRoleWhat they receive
EW Tricuspid Transcatheter Repair SystemExperimentalEdwards (EW) Tricuspid Transcatheter Repair System
Receives: Device: EW Tricuspid Transcatheter Repair System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 30 days.

Secondary outcomes (10)

  1. 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

    Measured: Implant Procedure

  2. 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

    Measured: At 1 month, 6 months, 1, 2, and 3 years

  3. 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

    Measured: At 1 month

  4. Clinical Outcomes [Heart Failure Re-Hospitalization Rates]

    Re-hospitalization rates for the underlying condition (heart failure)

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  5. Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]

    Re-intervention rates for the underlying condition (tricuspid regurgitation)

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  6. Clinical Outcomes [Changes in Peripheral Edema]

    Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  7. 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.

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  8. Clinical Outcomes [Change in 6 Minute Walk Test Distance]

    Change in 6 minute walk test distance (meters) compared to baseline

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  9. 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.

    Measured: At 1 month, 6 months, 1, 2 and 3 years

  10. 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.

    Measured: At 1 month, 6 months, 1, 2 and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study start14 Sep 2016
  3. Primary completion30 Jan 2018
  4. Study completion14 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787408
Sponsor's protocol ID
2015-09
Acronym
SPACER
Status last verified
Apr 2022
First submitted
11 Apr 2016
Last updated
25 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EW Tricuspid Transcatheter Repair System in people with Tricuspid Valve Regurgitation, run by Edwards Lifesciences at 11 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Canada, France, Greece, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: At 30 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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