Cardiology: Clinical Research Program

Eligibility

• Male or female, 22-85 years of age.
• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG.
• CHA2DS2-VASC score of 1-4 without prior stroke or TIA**
• The participant is on a DOAC at the time of screening.
• Inclusion/Exclusion Criteria: for matched healthy controls; Valvular or permanent atrial fibrillation, Current treatment with warfarin and unwilling or unable to take a DOAC.

Enrollment Status: Actively enrolling

Study Information

Grant # UG3HL15065

Principal Investigator

Jason Jacobson, MD

Contact for Study Screening

[email protected] or [email protected]

Eligibility

• Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
• Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format.
• The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):
  • Atrial fibrillation type
  • Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s).
• Subject is ≥ 22 years of age at time of enrollment/consent.
• Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
• Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study.
• Exclusion Criteria:
  • Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis).
  • Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads.
  • Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation.
  • Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.
  • Subjects who are pregnant as confirmed by the institution’s standard pre-surgery practice.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06935591

Principal Investigator

Sei Iwai, MD

Contact for Study Screening

[email protected]

Eligibility

• Males or females age >18
• Presence of BIV pacemaker or defibrillator
• Exclusion Criteria:
  • Unable or unwilling to provide consent
  • Non-English-speaking patients

Enrollment Status: Actively enrolling

Principal Investigator

Jason Jacobson, MD

Contact for Study Screening

[email protected]

Eligibility

• Men and women 18 and 75 years of age (inclusive) at the time of signing the ICF.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:
  • Idiopathic PAH
  • Heritable PAH
  • Drug/toxin-induced PAH
  • PAH associated with CTD
  • PAH associated with simple, congenital systemic-to-pulmonary shunts ≥1 year following repair
• Must have a BMI of ≥18.5 kg/m2 and ≤35.0 kg/m2 during screening.
• Baseline RHC performed during the screening period documenting a PVR of ≥400 dyn·sec·cm-5, a PCWP or left ventricular end-diastolic pressure of ≤15 mmHg, and an mPAP of >20 mmHg. If the population mean baseline PVR falls below 700 dyn·sec·cm-5, enrollment may be restricted to participants with a baseline PVR of ≥600 dyn·sec·cm-5 for the remainder of the study.
• On stable doses of background PAH therapy (≤3 PAH specific medications) including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days before screening. Current use of sotatercept is not permitted in this study.
• Anticipated to be able to perform the 6MWT according to American Thoracic Society Guidelines for the duration of the study.
• 6MWD ≥100 and ≤475 m repeated twice at screening (measured at least 4 hours but no longer than 1 week apart), with both values within 15% of each other (calculated from the highest value).
• NT-proBNP >300 ng/L during screening.
• If female and a WOCBP as defined in Section 7.2.1, must meet all the requirements below:
  • Agrees to use a contraceptive method that is highly effective (defined as having a failure rate of <1% per year as described in Section 7.2.2) from 30 days before dosing through 14 days after the last dose of study drug AND
  • Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction from at least 14 days prior to dosing through the end of the study AND
  • Has negative pregnancy tests at screening and before the administration of the first dose of study drug
• Exclusion Criteria:
  • Diagnosis of PAH WHO Groups 2, 3, 4, or 5.
  • Diagnosis of the following PAH Group 1 subtypes:
    • HIV-associated PAH
    • PAH associated with portal hypertension
    • Schistosomiasis-associated PAH
    • Pulmonary veno-occlusive disease
  • Diagnosis or history of any of the following substance-related conditions:
    • Methamphetamine-associated PAH
    • History of cocaine or methamphetamine (amphetamine-type stimulant) use within 24 months prior to screening defined by self-report, medical history, or positive drug screen in medical records
    • Any diagnosis of cocaine or methamphetamine use disorder (per medical record or self-report) within 24 months prior to screening
  • Uncontrolled diabetes mellitus, defined as HbA1c ≥9.0%.
  • Any of the following BP-related values or abnormalities:
    • Uncontrolled systemic hypertension as evidenced by sitting systolic BP >160 mmHg or sitting diastolic BP >100 mmHg at screening after 5 minutes of rest
    • Baseline systolic BP <90 mmHg at screening
    • Syncope within 3 months before screening
  • History of restrictive, constrictive, or congestive cardiomyopathy.
  • ECG with QTcF ≥450 msec in males or ≥470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.
  • Personal or family history of long QT syndrome or sudden cardiac death.
  • Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.
  • FVC <70% on PFT performed no more than 6 months before screening; or if FVC is 60% to 69%, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.
  • Evidence of LVEF <45% (by Simpson’s biplane method) or evidence of impaired relaxation on screening echocardiogram by E/e’ >13.
  • History of atrial fibrillation or atrial flutter.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT07365332

Principal Investigator

Erika Berman-Rosenzweig, MD

Contact for Study Screening

[email protected]