Menu
Enrolling by invitation NCT07057323

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

No phase Interventional Heart Failure Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary Sinus Reducer.
Who it may be relevant to
Registry conditions: Heart Failure Preserved Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction

Overview

The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.

Interventions

  • Device Coronary Sinus Reducer
    Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.

Primary outcome measures

  • Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise [Time frame: Baseline, 6 months]
Secondary outcome measures (12)
  • Change in Kansas City Cardiomyopathy (KCCQ-12) [Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
  • Change in Seattle Angina Questionnaire (SAQ) [Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
  • Change in New York Heart Association (NYHA) classification [Time frame: Baseline, 6 months]
  • Change in Canadian Cardiovascular Society (CCS) [Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
  • Change in Borg maximal perceived exertion scores [Time frame: Baseline, 6 months]
  • Change in maximum exercise capacity (VO2 max) during supine exercise testing [Time frame: Baseline, 6 months]
  • Change in transcardiac lactate release [Time frame: Baseline, 6 months]
  • Change in transcardiac lactate uptake [Time frame: Baseline, 6 months]
  • Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest [Time frame: Baseline, 6 months]
  • Change in Pulmonary Arterial Pressure at rest [Time frame: Baseline, 6 months]
  • Change in Pulmonary Arterial Pressure at exercise [Time frame: Baseline, 6 months]
  • Cardiac output [Time frame: Baseline, 6 months]

Eligibility criteria

Inclusion criteria

  • Able to provide written informed consent and willing to participate in all required study follow-up assessments
  • Clinical indicated coronary angiography with invasive CRT testing or PET with CRF assessment prior to enrollment. Abnormal CFR of ≤ 2.5 or PET CFR ≤ 2.0
  • Symptomatic HFpEF defined by (PAWP>15mmHg at rest and /or PAWP>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed prior to enrollment or during screening visit (if not performed clinically ).
  • Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR>0.89 or FFR>0.8 in vessels with 50 to 70% stenosis)

Exclusion criteria

  • Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery
  • Significant valvular heart disease moderate to severe regurgitation and or stenosis)
  • Primary cardiomyopathies (hypertrophic, infiltrative or restrictive)
  • Constrictive pericarditis
  • Severe myocardial bridging
  • Pregnancy
  • Recent (with 3 months) acute coronary syndrome
  • Subjects in Cardiogenic shock (systolic pressure<80mm/Hg)
  • Mean right atrial pressure at rest >15 mmHg
  • Anomalous or abnormal CS anatomy (e.g. tortuosity aberrant branch persistent left superior vena cava as demonstrated on angiogram
  • CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram.
  • Known severe reaction to required procedural medications
  • Known allergy to stainless steel or nickel
  • Magnetic Resonance Imaging (MRI) within 8 weeks after Reducer implantation
  • Chronic renal failure (serum creatinine>2mg/dL)
  • Severe chronic obstructive pulmonary disease (COPD) as indicated by forced expiratory volume in one second that is less than 55% of the predicted value or need for home daytime oxygen
  • Pacemaker electrode/lead in the coronary sinus
  • Moribund or with comorbidities limiting life expectancy to less than one year
  • Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
  • Inability or unwillingness of individual to give written informed consent.
  • Additional factors deemed unsuitable for trial enrollment per discretion of the Principal Investigator
  • Inmates

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07057323 · 25-002292

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗