Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)

Launched by ASSOCIAZIONE PORTATORI DISPOSITIVI IMPIANTABILI CARDIACI · Jul 13, 2018

Keywords

ClinConnect Summary

The CRT-NEXT clinical trial is studying a new device called the CRT-DX system, which is used for treating heart failure. The main goal of the trial is to see if this new system works just as well as the standard CRT-D system, particularly in preventing death, hospital visits for heart-related issues, and complications that might affect the device's performance. This trial is open to adults aged 18 and older who are in good heart rhythm and are currently receiving the best medical therapy for their condition.

To join the trial, patients need to meet certain criteria, such as having a specific heart rate and being able to walk a certain distance during a test. Participants can expect to undergo regular check-ups and monitoring while using the device to ensure their safety and to gather important information about its effectiveness. It's important to note that certain patients, like those with severe heart failure or those who are pregnant, will not be eligible for this study. Overall, this trial aims to help improve treatment options for people with heart failure.

Gender

ALL

Eligibility 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.