Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (NCT02922036)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. /Exclusion: Inclusion Criteria
2. Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
3. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
4. Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to \< 150ms
5. Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
6. Patient is a:
7. 'Non-responder' \[Not Enrolling\]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
8. EF has remained unchanged or worsened (defined as \< 5% increase since implant), and
9. The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee OR
10. 'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons: i. Patients in whom CS lead implantation for CRT has failed
11. CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges ii. CS lead implanted but has been programmed OFF
12. LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location OR c. 'High Risk Upgrade: Patients who have a relative contraindication to CS lead implant, due to:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (68 Sites)

• Heart Center Research — Huntsville, Alabama
• University of California, San Diego — La Jolla, California
• Broward Health Medical Center — Fort Lauderdale, Florida
• St. Vincent's Healthcare — Jacksonville, Florida
• Watson Clinic — Lakeland, Florida
• Naples Community Hospital — Naples, Florida
• Northside Hospital and Heart Institute — St. Petersburg, Florida
• Piedmont Heart Institute — Atlanta, Georgia
• Emory Healthcare — Atlanta, Georgia
• Prairie Heart — Springfield, Illinois
• St. Vincent's Hospital and Healthcare Center — Indianapolis, Indiana
• University of Iowa — Iowa City, Iowa
• Saint Luke's Health System Kansas City — Kansas City, Kansas
• The University of Kansas Medical Center — Kansas City, Kansas
• Baptist Health Lexington — Lexington, Kentucky
• Ochsner Medical Center - Baton Rouge — Baton Rouge, Louisiana
• University of Michigan — Ann Arbor, Michigan
• Michigan Heart — Canton, Michigan
• Henry Ford Hospital — Detroit, Michigan
• William Beaumont Hospital — Hazel Park, Michigan
• Sparrow Hospital — Lansing, Michigan
• Minneapolis Heart Institute — Minneapolis, Minnesota
• Mayo Clinic — Rochester, Minnesota
• United Heart and Vascular Clinic — Saint Paul, Minnesota
• Methodist Physicians Clinic Heart Consultants — Omaha, Nebraska

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.