The main objective of the study is to investigate whether early repair (within 60 days after a heart attack) of the mitral valve, using a non-surgical transcatheter technique (TEER) in combination with the standard medical therapy required for the…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint [Time Frame: 12 months]:
Composite of
1. All-cause death
2. Cumulative HF hospitalizations
Secondary outcome
Secondary endpoints [Time Frame: 24 months]:
1. Quality of Life (QOL) assessed using KCCQ-12 (Appendix I)
2. New York Heart Association (NYHA) functional class (Appendix II)
3. LV remodeling parameters (e.g., LV size, LV function, pulmonary pressures,
RV function)
4. Mitral Regurgitation (MR) severity
5. Myocardial infarction (MI)
6. Stroke
7. Renal complication with requirement for dialysis
8. Major vascular complications
9. Major and/or life-threatening bleeding
10. Need for mitral valve surgery
In addition, all heart failure (HF) events according to latest working group
definition will be recorded in the CRF for additional analyses.
Background summary
Mitral valve regurgitation, also known as mitral valve insufficiency, is a
condition where the mitral valve in the heart does not close properly. This
allows blood to flow back from one of the two lower chambers of the heart (left
ventricle) to the upper chamber on the left side of the heart (left atrium),
whereas blood should only flow in one direction, from the left atrium to the
left ventricle. Left untreated, mitral valve insufficiency can damage the
heart. To prevent this, medication is prescribed, and depending on the
progression, open-heart surgery may be considered (only if the patient's risk
is not too high).
In recent years, a new technique has been developed and widely used in daily
clinical practice to repair the mitral valve in certain specific cases using a
catheter, without the need for open-heart surgery. This method, also known as
transcatheter Edge-to-Edge Repair (TEER), is particularly suitable for patients
for whom surgery may pose risks and has already been successfully applied in
many situations. The procedure involves making a small incision in the femoral
vein (known as transfemoral access, i.e., "via the right or left femoral
vein"), while the patient is under anesthesia. The mitral valve placement
system (a catheter) passes through the femoral vein and reaches the heart
without opening the chest or stopping the heart.
We are conducting this research to evaluate the best treatment method in this
situation: using the standard treatment method with medication alone, or
combining the standard treatment method with medication with repair using a
non-surgical transcatheter technique (TEER method). In this technique, one or
more clips (MitraClip) are used to grasp and connect the mitral valve leaflets,
reducing mitral valve insufficiency. The evaluation conducted during this
research investigates the different treatment methods, all of which are already
applied in contemporary practice.
Study objective
The main objective of the study is to investigate whether early repair (within
60 days after a heart attack) of the mitral valve, using a non-surgical
transcatheter technique (TEER) in combination with the standard medical therapy
required for the heart condition, reduces the risk of death and long-term
hospitalizations due to heart problems in the year following the procedure. The
study will evaluate, through a two-year follow-up, how this treatment affects
your quality of life and the functionality of your heart.
All devices, medications, and procedures used in this study are commercially
approved and constitute standard care.
Study design
Prospective, multicenter, randomized, open-label, comparative effectiveness
clinical trial for the treatment of clinically significant functional mitral
regurgitation within 60 days after acute myocardial infarction, who are treated
per Standard Medical Therapy per Institution Guidelines (SMTIG) and who have
been determined by the site's local Heart Team as inappropriate or too high
risk for mitral valve surgery.
Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device
(interventional group) or to the Standard Medical Therapy per Institution
Guidelines alone (control group).
Study treatment starts after randomization, follow-up will start after initial
study treatment was done (Time of TEER for the interventional group or 1 months
after randomization for the control group). Medical therapy will be adjusted to
patient needs during the whole follow-up period, treatment choices will be left
at the discretion of the treating physicians. This means that the treating
physician can decide to switch participants from one group to the other.
Intervention
In the study, the repair of the mitral valve using a catheter is considered the
intervention. However, this is already a standard treatment and is applied
daily in the hospital.
A brief explanation:
In recent years, a new technique has been developed that is widely used in
daily clinical practice: repair of the mitral valve using a catheter. This
method is also known as the "Transcatheter Edge-to-Edge Repair (TEER)." It is a
non-surgical transcatheter technique where one or more clips (MitraClip) are
used to grasp and connect the mitral valve leaflets, thereby reducing mitral
valve insufficiency. The procedure is performed by making a small incision in
the femoral vein (so-called transfemoral access, i.e., "via the right or left
femoral vein"), while the patient is under anesthesia. The mitral valve
placement system (a catheter) goes through the femoral vein and reaches the
heart without opening the chest or stopping the heart.
Study burden and risks
Treatment as part of this study is identical to treatment outside of this
study. Participation in the study will not impact the procedure or use of the
device in any way.
Potential risks associated with the TEER procedure are well known and accepted.
The potential complications listed in the IFU of the study device, would be
explained to the patients regardless of study participation.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
1. Patients with symptomatic moderate to severe or severe MR that develops
after acute myocardial infarction (AMI)
2. Age > 18 years
3. Clinical presentation of AMR must fulfill one of the following scenarios, as
proposed by Shuvy et al. [1]:
a. TYPE 2: Refractory pulmonary edema; systolic blood pressure (SBP) > 90mmHg;
Low output state (e.g. oliguria) but normal lactate levels; Requirement for
continuous intravenous diuretic; Requirement for urgent valvular intervention
b. TYPE 3: SBP > 90 mmHg; might be in low cardiac output State; Episodes of
pulmonary edema; Intermittent IV diuretics; May Require valvular intervention
c. Type 4: Mild-Moderate HF; Might require oral diuretic therapy; Typically
treated medically, but late LV remodeling may be very unfavorable; Role of
valvular intervention is uncertain.
4. Written informed consent
Exclusion criteria
1. Primary MR (e.g. papillary muscle rupture)
2.Clinical presentation of AMR fulfills the following scenario, as proposed by
Shuvy et al. [1]:
TYPE 1: Cardiogenic shock: SBP < 90 mmHg + pulmonary edema; Elevatored lactate
levels; Requirement for inotropic therapy and/or mechanical support;
Requirement for urgent valvular intervention.
3.EF <= 25%
4. Accepted for CABG
5.Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip
positioning on the leaflets or sufficient reduction in MR by the MitraClip.
This evaluation is based on transesophageal echocardiogram (TEE) evaluation of
the mitral valve.
6. Subjects in whom transesophageal echocardiography (TEE) is contraindicated
or high risk.
7. Known hypersensitivity or contraindication to procedural medications which
cannot be adequately managed medically.
8. Pregnant or planning pregnancy within next 48 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06282042 |
| CCMO | NL86971.100.24 |