To collect long term outcomes on the use of the Neovasc Reducer
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of subjects who experience improvement in their angina symptoms
defined as a reduction in CCS grade, at 6 months as compared to baseline
The rate of occurrence of device and / or procedure related periprocedural
Serious Adverse Events (SAEs) defined as a composite of death, myocardial
infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer,
lifethreatening arrhythmias (ventricular tachycardia [VT] or
ventricular fibrillation [VF]), and respiratory failure through 30 days
post-implant
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major
stroke, and MI through 30 days post implant
Secondary outcome
The percentage of subjects who experience improvement in their angina symptoms
defined as a reduction in CCS grade at 12 months and annually through 5 years
post implant as compared to baseline
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major
stroke, and MI at 6 months, 12 months and annually through 5 years post implant
Background summary
The Reducer is intended for patients with refractory angina pectoris despite
medical therapy, who are either not amenable or are at high risk for
revascularization by coronary artery bypass grafting (CABG) or by percutaneous
coronary intervention (PCI). The Reducer is designed to create a narrowing in
the coronary sinus (CS) after implantation. CS narrowing improves perfusion to
ischemic myocardium in the presence of reversible ischemic heart disease to
alleviate the symptoms of refractory angina pectoris.
Study objective
To collect long term outcomes on the use of the Neovasc Reducer
Study design
A multi-center, multi-country, three-arm observational study.
Arm 1: Subjects are enrolled prior to receiving the Reducer.
Subjects will be followed at baseline, implant procedure, 30 day (phone visit),
6 and 12 months post implant and annually through 5
years.
Arm 2: Subjects who were previously enrolled and treated with the Reducer,
during the COSIRA study will be invited to participate in
this long term follow up study. This arm will collect both retrospective and
prospective data.
* Data previously collected from the treatment arm of the COSIRA study
(baseline, procedure, 30 days and 6 month
post implant) will be included in this arm
* Retrospective data (prior to consent) and/or prospective data (after consent)
will be collected at 12 months post
implant and annually through 5 years post implant
Arm 3: Subjects who received a Reducer under CE Mark (unrelated to the COSIRA
study), will be invited to participate. This
arm will collect both retrospective and prospective data.
* Available baseline and procedure data will be collected retrospectively
* Retrospective and/or prospective data will be collected at 30 days, 6 months,
12 months post implant and annually through 5 years post implant
Study burden and risks
.
13562 Maycrest Way, suite 5138
Richmond, British Columbia V6V 2J7
CA
13562 Maycrest Way, suite 5138
Richmond, British Columbia V6V 2J7
CA
Listed location countries
Age
Inclusion criteria
Arm 1:
• Symptomatic CAD with chronic refractory angina pectoris classified as CCS
grade II, III or IV despite attempted optimal medical therapy
• Subject has limited treatment options for revascularization by CABG or by PCI
• Evidence of reversible myocardial ischemia in at least one of the following
objective clinical tests performed up to 6 months prior to consent:
Thallium/Methoxyisobutyl Isonitrile (MIBI) Single Photon Emission Computed
Tomography (SPECT), Dobutamine Stress Echo (DSE), Perfusion magnetic resonance
imaging (MRI), Exercise Tolerance Testing (ETT)
• Left ventricular ejection fraction (LVEF) greater than or equal to 30%
• Male or non-pregnant female (If required by institutional procedures, females
of childbearing
potential must have a negative pregnancy test)Arm 2:
• Subjects previously implanted in the Reducer (treatment) arm of the COSIRA
studyArm 3:
• Subjects in whom the Reducer was implanted under CE Mark (unrelated to the
COSIRA study), prior to enrollment in the REDUCER-I studyAll Arms:
• Subject has been informed about the study and provides written informed
consent prior to
enrollment
• Subject is willing to comply with specified follow-up evaluations and can be
contacted by telephone
Exclusion criteria
Arm 1:
• Recent (within three months) acute coronary syndrome
• Recent (within six months) PCI or CABG
• Unstable angina (recent onset angina, crescendo angina, or rest angina with
electrocardiogram
[ECG] changes) during the 30 days prior to baseline
• Decompensated congestive heart failure (CHF) or hospitalization due to CHF
during the three
months prior to baseline
• Life threatening rhythm disorders or any rhythm disorders that would require
placement of an
internal defibrillator and / or pacemaker
• Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced
expiratory volume in one second that is less than 55% of the predicted value
• Subject cannot undergo exercise tolerance test or 6-minute walk test for
reasons other than
refractory angina
• Severe valvular heart disease
• Subject with pacemaker or defibrillator electrode in the right atrium (RA),
right ventricle
(RV), or CS
• Subject having undergone tricuspid valve replacement or repair
• Chronic renal failure (serum creatinine >2 mg/dL), including subjects on
chronic hemodialysis
• Moribund subjects, or subjects with comorbidities limiting life expectancy
to less than one year
• Contraindication to required medications that cannot be adequately
controlled with
pre-medication
• Known allergy to stainless steel or nickel
• Currently enrolled in another device or drug trial that has not completed
the primary
endpoint or that clinically interferes with the current study
endpointsAngiographic Exclusion
• Mean right atrial pressure greater than or equal to 15 mmHg
• ubject with anomalous or abnormal CS as demonstrated by angiogram.
Abnormality defined as:
• Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left
superior vena cava [SVC])
and/or;
• CS diameter at the site of planned Reducer implantation less than 9.5 mm or
greater than 13
mm• Mean right atrial pressure greater than or equal to 15 mmHg
• Subject with anomalous or abnormal CS as demonstrated by angiogram.
Abnormality defined as:
• Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left
superior vena cava [SVC])
and/or;
• CS diameter at the site of planned Reducer implantation less than 9.5 mm or
greater than
13 mm
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 |
|---|---|
| CCMO | NL55679.041.16 |