Home › Trials › NCT03587064

Comparing two types of heart devices for heart failure treatment

Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems

Not applicable Interventional Associazione Portatori Dispositivi Impiantabili Cardiaci · NCT03587064

This study is testing whether a new type of heart device works just as well as the standard one for people with heart failure who don't have certain heart rhythm issues.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment640 (estimated)
Ages18 Years and up
SexAll
SponsorAssociazione Portatori Dispositivi Impiantabili Cardiaci Academic / other
Locations24 sites (Rho, Milano and 23 other locations)
Trial IDNCT03587064 on ClinicalTrials.gov

What this trial studies

This investigation aims to evaluate the non-inferiority of the CRT-DX system compared to the conventional CRT-D system in patients with heart failure who do not show sinus dysfunction. The study focuses on the combined outcomes of mortality, cardiovascular-related hospitalizations, and complications affecting lead functionality. It explores the effectiveness of different pacing strategies, particularly the necessity of atrial pacing support in patients receiving cardiac resynchronization therapy. The trial will involve the implantation of either a conventional 3-lead or a 2-lead CRT defibrillator system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with indications for CRT-D implantation and optimized medical therapy, who are in sinus rhythm and have a resting heart rate above 45 bpm.

Not a fit: Patients who may not benefit include those requiring atrial pacing, those with resting heart rates below 45 bpm, or those with severe heart failure (NYHA Class IV).

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for heart failure patients, potentially reducing complications and hospitalizations.

How similar studies have performed: Previous studies have shown mixed results regarding pacing strategies in heart failure, indicating that this approach may provide new insights but is not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female patients ≥ 18 years old
2. Patients willing to participate in the investigation and signing the Patient Informed Consent (PIC) Form;
3. Indication to CRT-D implant according to current ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
4. Sinus rhythm at time of implant;
5. Optimized medical therapy according to current ESC Guidelines
6. Rest heart rate (HR) \>45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage; or, if rest HR\<45 bpm: maximum heart rate at the 6- minute walking test \>85 bpm.

Exclusion Criteria:

1. Any indication to atrial pacing according to current guidelines;
2. Both: resting heart rate \<45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage and maximum heart rate at the 6-minute walking test \<85 bpm;
3. NYHA Class IV;
4. Permanent Atrial Fibrillation
5. Replacement of/upgrading from previously implanted pacing system;
6. Dialysis patients;
7. Pregnant or breast-feeding women.

Where this trial is running

Rho, Milano and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureCardiac Resynchronization TherapyCRT-DCRT-DXAtrial pacing
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.