New indication expansion for CRT-D in patients with heart failure.

Trial ID:
IRB-25-8685
Nicholas Olson, MD

Inclusion Criteria

Patients must:

  • Be 18 years of age.
    Meet guideline- based indication for a de novo CRT-D device.
    Have NYHA class II-IV
    Be willing to participate in LATITUDE™ NXT remote patient monitoring.
    Plan to remain geographically stable (not permanently moving to another location) and can commit to all study participation.

Exclusion Criteria

Patients must not:

  • Have persistent or permanent atrial fibrillation within 3 months prior to enrollment.
    Have current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers).
    Have prior or planned mechanical or bioprosthetic tricuspid valve replacement.
    Have unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment.
    Be requiring dialysis.
    Be enrolled in any other concurrent study.

Additional Info

The study is going to look at how providing heart failure treatment from an alternative location in the heart performs in patients with your medical history compared to the standard location in the heart where it is currently provided. The CRT-D system locations where the leads will be placed are already approved for treatment of other medical conditions, but not for treating heart failure.

The procedure will take place at Scripps Memorial Hospital, and all office visits will take place in the Scripps Clinic Anderson Medical Pavilion.

For more information search NCT # NCT07069738 on the website www.ClinicalTrials.gov

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org