Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT05592392
Eligibility Criteria:
Inclusion Criteria:
* NYHA classes II/III on optimal Guideline Directed Medical Therapy
* QRS duration ≤ 130 ms
* LVEF \< 40%
* Willing and able to comply with protocol requirements, including attending all required visits
* Wiling to participate in the study and able to sign an informed consent form
Exclusion Criteria:
* Baseline 6-minute walk test \> 500 meters or \< 200 meters
* NT-proBNP\< 250 if on loop diuretics, or NT-proBNP \< 500 if not on loop diuretics
* Supine resting heart rate \> 140 bpm
* Systolic blood pressure \< 80 mmHg or \> 170 mmHg
* Serum creatinine \> 2.5 mg/dL
* Serum hepatic function 3x ULN
* Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months
* Intermittent IV inotropic drug treatment
* Arrhythmias present during screening (profound ectopy, bradycardia, profound prevalence of ectopy, NSVT, VF, AF\*, SVT or AFLT) - \* see enrollment exception allowing for 10 patients in AF for a separate subgroup analysis
* Reversible non-ischemic cardiomyopathy
* Primary valvular disease
* Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest
* Severe COPD, other respiratory or lung diseases where FEV \< 50%
* Pericardial disease
* Diabetic neuropathy
* Existing diaphragmatic stimulation for respiration assist
* LVAD or other mechanical cardiac assist devices
* Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
* Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
* Previous open laparotomy within 1 year
* Previous thoracic or abdominal organ transplant
* Drug induced immuno-suppression
* Body mass index \> 40
* Enrollment in a concurrent investigation / clinical study
* Having a life expectancy of \<1 year due to any condition
* Pregnant or planning a pregnancy during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05592392
Study Brief:
Protocol Section:
NCT05592392