Cardiomyopathy Clinical Trials

• Older than 18 years of age.

• Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure. Note: The LVEF must be reassessed after any intervening myocardial infarction. The most recent LVEF assessment is used as the qualifying test for subjects with multiple assessments

• Greater than or equal to 30 days of persistent symptomatic coronary microvascular dysfunction (angina pectoris, or equivalent symptoms) (classified as CCS Grade II - IV angina, or NYHA Class 2 or 3 equivalent non-anginal functional impairment) despite optimal medical therapy, as determined by Investigator and confirmed by the Central Screening Committee. Note: Optimal medical management is defined as at least 2 anti-anginal medications or maximally tolerated medical therapy if less than 2 anti-anginal medications.

• CFR\<2.5 measured with continuous thermodilution within 30 days of index procedure. Note: CFR assessment may be completed during index procedure by Sponsor approved Investigators. RCA measurements are not permitted for this study.

• Note: CFR should be measured in LAD or LCX if LAD is not feasible. RCA measurements are not permitted for this study

• Sustained angina (or equivalent symptoms) reported for at least 2 weeks leading up to the index procedure, as reported via the ORBITA-app.

• Willing and able to sign informed consent.

• Willing to comply with the specified follow-up evaluations.

• Procedural Angiographic/Hemodynamic Inclusion Criteria:

• The following will be assessed during the index procedure to confirm eligibility before an attempt at implantation. Note: CFR assessment may be completed during index procedure by Sponsor approved Investigators if not yet obtained in the prior 30 days (see inclusion criteria 4).

• Mean right atrial pressure ≤15 mmHg.

• The CS anatomy is suitable for implantation at the Investigator's discretion