Primary Objective: Improvement in myocardial blood flow and reverse remodelingSecondary Objective(s): Improvement in wall motion abnormalities, left ventricular function and NYHA class
ID
Source
Brief title
Condition
- Heart failures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement in myocardial blood flow and occurrence of reverse remodeling after
treatment of patients with Ni-Cath based on MRI.
Secondary outcome
Secondary endpoints consist of wall motion abnormalities, left ventricular
function, and improvement in NYHA class based on MRI and Quality Of Life score.
Background summary
Management of patients with ischemic cardiomyopathy is a major challenge for
the cardiologist and cardiac surgeon. Patients with advanced ischemic
cardiomyopathy frequently have limited symptoms with recurrent angina, angina
at low work thresholds, breathlessness, and other debilitating conditions.
Surgical and interventional options for these patients typically have been
exhausted or will result in only partial revascularization. Therefore, therapy
remains limited to the use of multiple anti-anginal medications, reduced
activity, exertion, and stress level, and significant alteration and limitation
of lifestyle.
A new Non-Invasive Cardiac Angiogenesis Therapy (NI-CATh) was developed
recently which couples the ability of low intensity shock waves to induce
angiogenesis to the therapy of angina and is becoming a new alternative in the
treatment of these patients.
The NI-Cath will lead to a decrease of the size of the ischemic zone and an
improvement in myocardial blood flow, reverse remodeling and NYHA class in
patients with ischemic cardiomyopathy
Study objective
Primary Objective: Improvement in myocardial blood flow and reverse remodeling
Secondary Objective(s): Improvement in wall motion abnormalities, left
ventricular function and NYHA class
Study design
Since there will be no control group and thus there is no randomization, the
study will be performed as a longitudinal study.
Study burden and risks
The research involves a low burden, which consists of a frequent visit to the
outpatient clinic for the treatment with the device. There are no known major
adverse events with the use of the device, so the risk for the subject is also
low.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
* Patient is male or female 18 years or older.
* Patient is diagnosed with ischemic cardiomyopathy. I.e. a significantly impaired left ventriculair dysfunction (left ventricular ejection fraction * 35 to 40 percent) that results from coronary artery disease based on a coronary angiogram.
* Patient has documented myocardial segments with reversible ischemia and or hibernation.
* Patient is classified as NYHA class II-IV.
* Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion / restenosis following traditional revascularization.
* Patient has refused to undergo another angioplasty or CABG.
Exclusion criteria
* Patient has chronic lung disease including emphysema and pulmonary fibrosis.
* Patient has active endocarditis, myocarditis or pericarditis.
* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization.
* Patients who are unwilling or unable to cooperate with study procedure.
* Patients with renal dysfunction with eGFR<30 ml/min
* Patients who are unwilling to quit smoking during the study procedure (including screening phase)
* Patients who had MI less than 3 months prior to treatment
* Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
* Patient with intraventricular thrombus
* Patient is pregnant
* Patient with a malignancy in the area of treatment
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 |
|---|---|
| CCMO | NL23935.029.08 |