The objective of this study is to evaluate the safety and performance of the DaVingi* TR System for the treatment of patients with functional tricuspid regurgitation within its intended use.The study will:• Evaluate the safety and feasibility of…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoints
- Implant Device SADE: the incidence and severity of device-related serious
adverse device effects (SADE) from time of index implant procedure through 30
days post-implant.
- Adjustment Device SADE: the incidence and severity of device-related serious
adverse device effects (SADE) from time of index adjustment procedure through
30 days post-adjustment.
Performance Endpoints
- Implant Device Technical Success: Rate of successful delivery, deployment and
implantation of a DaVingi* TR ring onto the tricuspid annulus, defined as
(a) number of stakes embedded in tissue at the end of the procedure (by
fluoroscopic and/or echocardiographic assessment)
(b) the ring is in stable position on the atrial side of the tricuspid valve as
evidence by post-procedure cine CT showing concordant motion of the stakes with
the plane of the tricuspid annulus.
Note: Implant Device Technical Success shall be assessed at the time of the
index procedure after all DaVingi* TR ring devices have been used at the
annulus
- Adjustment Device Technical Success: Rate of successful adjustment of the
DaVingi* TR ring at the tricuspid annulus (i.e., level of annular contraction
desired by physician is achieved).
The co-primary performance endpoint will also be reported for each individual
component of the endpoint.
Secondary outcome
Safety Endpoints
• Incidence of device-related major adverse cardiac events (MACE)5 through 30
days post-implant and through 365 days post-index adjustment procedure.
• Rate of procedure-related serious adverse events (SAE) through 30 days
post-implant and through 365 days-post index adjustment procedure.
Performance Endpoints
• Implant Procedural Success: Implant Device Technical Success met and no
SADE(s) within 24 hours post index implant procedure.
• Adjustment Procedural Success: Adjustment Device Technical Success met and no
SADE(s) within 24 hours post index adjustment procedure.
• Ability to maintain improvement in TR: at 30, 90, 180- and 365-days
post-index adjustment procedure, relative to baseline.
• Change in Quality of Life assessment: by KCCQ at 90, 180- and 365-days years
post-index adjustment procedure, relative to baseline.
• Change in 6MWT: at 90, 180, and 365 days post-index adjustment procedure,
relative to baseline.
• Number of heart failure hospitalizations: through 365 days post-index
adjustment procedure, as compared to 365-day interval prior to enrollment.
• The need for re-intervention for TR: at 30, 90, 180- and 365-days post-index
adjustment procedure.
• Changes in NYHA Class: at 30, 90, 180- and 365-days post-index adjustment
procedure, relative to baseline.
Background summary
Functional TR (tricuspic regurgitation) is primarily due to tricuspid annular
dilation and right ventricular (RV) enlargement and dysfunction; it occurs most
often secondary to left-sided heart disease, especially in the setting of
mitral valve pathology.
The tricuspid valve has three leaflets (anterior, posterior, and septal). The
anterior leaflet is largest in surface area and is almost always staked by a
single papillary muscle; affected most by annular dilation, functional TR
occurs when annular dilation reduces coaptation of the anterior leaflet. RV
enlargement can result in papillary muscle displacement, another mechanism of
functional TR.
Repair of the leaking tricuspid valve curently involves a surgical procedure to
fix a ring around the atrial side of the annulus of the tricuspid valve. The
surgical treatment can have significant risk for patients with other
comorbidities.
Cardiac Implants is developing a percutaneous catheter-based device to repair
tricuspid regurgitation. The device is designed to deliver a small, flexible,
fabric covered ring around the atrial side of the annulus of the tricuspid
valve. Once implanted, the ring is left in place for 90 days until the ring and
the stakes are embedded in new connective tissue grown due to normal foreign
body reaction. This process is designed to secure the ring in place and allow
safely adjusting the annulus of the valve using the ring*s internal adjustment
cord under physiologic conditions and with echocardiographic guidance in order
to diminish valve regurgitation.
The annuloplasty ring is a small multi-element ring, consisting of an outer
fabric layer, a pre-set stake array and internal adjustment cord that can be
adjusted at a later chronic stage after the outer layer of the ring and stakes
are encapsulated in new tissue growth. Once implanted, the ring is designed to
serve as a foundation for promoting new annular tissue growth, effectively
growing a new adjustable annulus around the valve.
In this study, the ring will be delivered percutaneously or via surgical
venotomy, to accommodate a 22F vascular sheath size using a right jugular vein
access approach.
The Cardiac Implants progressive approach to valve annuloplasty repair is
designed to enable a low risk and effective means for physicians to perform
valve annuloplasty as a treatment for annular dilatation and valve
regurgitation of heart valves.
Study objective
The objective of this study is to evaluate the safety and performance of the
DaVingi* TR System for the treatment of patients with functional tricuspid
regurgitation within its intended use.
The study will:
• Evaluate the safety and feasibility of delivery & implantation of
annuloplasty ring.
• Evaluate the safety and feasibility of ring adjustment following healing
period.
• Evaluate the effect of annuloplasty on tricuspid regurgitation.
Study design
The study is a prospective open label, multi center first-in-human study. Up to
30 subjects will be treated.
Intervention
The enrolled patient will undergo 2 interventions.
1) The index implant procedure. The initial percutane transkatheter
implantation of the Cardiac Implants DaVingi* TR annuloplastyring.
2) The index adjustment procedure visit at 90 days post implantation. The
percutane transkatheter adjustment of the implanted Cardiac Implants DaVingi*
TR annuloplastyring using the same technique as for the implantation.
Study burden and risks
Benefit (Protocol 5.2.1)
1. The Cardiac Implants DaVingi* TR System is expected to bear a significant
lower risk than cardiac surgery.
2. Moreover, it may be the only option for a group of patients with additional
comorbidities, in the presence of high risk for surgery (after maximizing the
medical therapy (i.e. diuretics)) and deteriorating symptomatic disease state.
3. In addition, the investigational device is not preventing an implanted
subject from being treated later with any know therapy (percutaneous or
surgical) across the valve, such as: pacemaker lead implantation, ablation,
surgical annuloplasty and valve replacement.
(Protocol 18.6) As noted in the protocol section, for purposes of this study,
various events are not considered reportable adverse events because they are
normally expected to occur in conjunction with treatment of tricuspid
regurgitation or structural heart interventional procedures, or are associated
with customary, standard care of subjects undergoing minimally invasive
cardiovascular intervention.
(Protocol 18.10) Possible risks and adverse events that may be associated with
the DaVingi* TR System are based on adverse events reports of similar cardiac
implant devices and include, but are not limited to the following:
• Abnormal lab values (including electrolyte imbalance)
• Allergic reaction to antiplatelet agents, contrast medium, or anesthesia
• Anemia
• Bowel ischemia
• Cardiac arrhythmias including cardiac arrest, conduction system disturbances
(e.g., atrioventricular node block, left-bundle branch block, asystole), which
may require a permanent pacemaker
• Cardiac tamponade
• Cardiogenic shock
• Cardiorenal syndrome
• Coronary occlusion, obstruction, or vessel spasm (including acute coronary
closure)
• Device or components embolization
• Emergent percutaneous coronary intervention (PCI)
• Emergent surgery (e.g., coronary artery bypass, heart valve replacement/
repair, valve explant)
• Heart failure
• Heart murmur
• Hemolysis
• Hypotension or hypertension
• Infection (including septicemia and endocarditis)
• Lungs injury/trauma
• Major or minor bleeding that may or may not require transfusion or
intervention (including life-threatening or disabling bleeding)
• Myocardial infarction
• Myocardial ischemia
• Native valve dysfunction including, but not limited to, fracture; pannus;
leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture
breaks or disruption; leaks; mal-sizing (ring-patient mismatch);
malposition/misplacement; regurgitation; stenosis
• Pericardial effusion
• Peripheral ischemia
• Permanent disability
• Pulmonary edema
• Pulmonary effusion
• Renal failure
• Renal insufficiency or renal failure (including acute kidney injury)
• Reoperation (transcutaneous or surgical)
• Respiratory insufficiency or respiratory failure
• Ring partial attachment, late detachment or ring embolization
• Rupture/ perforation of the myocardium or a vessel
• Skin, endocardium or valve apparatus erosion
• Stroke, transient ischemic attack (TIA), or other neurological deficits such
as encephalopathy
• SyncopeDyspnea
• Thrombosis/embolus (including ring or components thrombosis)
• Tricuspid valve regurgitation or injury
• Vascular access related complications (e.g., dissection, perforation, pain,
bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment
syndrome, arteriovenous fistula, stenosis) that may require vascular surgery
• Elevated liver enzymes
There are additional risks that could possibly be associated with the tests and
procedures performed for the clinical study. These potential risks are
described below:
• Risks related to the blood tests required for the study, e.g., excessive
bleeding, fainting or light- headedness, hematoma, infection, or the
requirement of multiple punctures to locate a vein to draw the sample.
• Risks related to central venous pressure measurement, e.g., infection,
irregular heart-beats, collapsed lung, bleeding or death.
• Risks related to radiation; X-ray and CT imaging are required in addition to
the routine care. The additional radiation dose for these tests is limited.
• Risks related to transesophageal echocardiography (TEE), e.g. some risks are
associated with the medicine that might be used for sedation during TEE,
including allergic reaction to medication, breathing difficulty, or nausea. TEE
may also cause throat soreness, and rarely damage to the teeth or esophagus.
Lake Terrace 25
Tarrytown NY 10591
US
Lake Terrace 25
Tarrytown NY 10591
US
Listed location countries
Age
Inclusion criteria
1. Moderate to Severe functional tricuspid regurgitation (FTR) as defined by
ASE2.
2. Symptoms of right ventricular (RV) failure despite guideline directed
medical therapy, NYHA Class II-IV.
3. Multidisciplinary heart team (minimum of three physicians, including Imaging
and heart Failure cardiologists and cardiac surgery representatives) agree that
percutaneous tricuspid annuloplasty is a reasonable treatment option and
consider the subject to be a high risk for surgical annuloplasty.
4. >=18 years old at time of enrollment.
5. LVEF >= 30% within 45 days prior to index implant procedure.
6. PASP < 70 mmHg within 90 days prior to index implant procedure.
7. Right Ventricle TAPSE >= 13 mm within 45 days prior to index implant
procedure.
8. Tricuspid valve annular diameter >= 40 mm as measured by baseline TTE in the
4 chamber view within 45 days prior to index implant procedure.
9. Subject has provided written informed consent.
10. Subject agrees to comply with all required post-procedure follow-up visits,
including device adjustment.
Exclusion criteria
1. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV
inotropes).
2. Severe RV dysfunction per ASE guidelines3.
3. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
4. Previous tricuspid valve repair or replacement.
5. Transvalvular pacemaker or defibrillator lead is present.
6. Severe left-sided valve disease.
7. Right-sided intra-cardiac mass, thrombus or vegetation is present.
8. Inability to properly guide the index implant procedure using TEE (e.g.
acoustic window not adequate).
9. MI or known unstable angina within the 30-days prior to the implant index
procedure.
10. CVA within 3 months prior to index implant procedure.
11. Bleeding disorders, active peptic ulcer or GI bleed.
12. Contraindication to anticoagulation or antiplatelet medication, based on
investigator*s opinion.
13. Chronic oral steroid or immunomodulator use (>= 6 months) or other condition
that could impair healing response (e.g. cardiac sarcoidosis or other chronic
inflammatory disease).
14. Any condition that, in the opinion of the investigator, may render the
subject unable to complete the study (life expectancy < 1 year), or lead to
difficulties for subject compliance with study requirements.
15. Subject is enrolled in another investigational study which has not
completed the required primary endpoint follow-up period (Note: patients
involved in a long-term surveillance phase of another study are eligible for
this study).
16. Female patients who are pregnant or lactating.
Design
Recruitment
Medical products/devices used
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 | NCT03700918 |
| CCMO | NL74979.100.20 |