Heart failure & cardiomyopathiesRandomised controlled trial
Role of Atrial Pacing Support in Cardiac Resynchronization Therapy: A Noninferiority Randomized Trial
- Randomised controlled trial
- parallel-group
- noninferiority
- patients and primary outcome assessors blinded
- centralized block randomization stratified by site
- 23 Italian sites
Authors' conclusion
The 2-lead CRT-DX system without atrial pacing is noninferior to conventional 3-lead CRT-D, with fewer atrial lead-related complications.
Study context
- Population
- Patients with standard cardiac resynchronization therapy-defibrillator (CRT-D) indication, optimized medical therapy and resting sinus rate ≥45 beats/min, without sinus node dysfunction
- Participants
- 636 patients
- Comparison
- 2-lead CRT-DX vs 3-lead CRT-D with conventional atrial lead
- Primary endpoint
- Composite of:
- All-cause mortality
- CV hospitalization
- Lead-related complications (loss of functionality not correctable by device reprogramming)
- Follow-up
- 1 year
Primary result
As reported in the abstract
Hazard ratio
0.82
95% CI 0.54–1.25
Events by treatment group
CRT-DX vs CRT-D
HR 0.82 (95% CI 0.54–1.25)
Secondary outcomes
Lead complications related to right atrial functionality
P = 0.040
| Outcome | CRT-DX | CRT-D | P value |
|---|---|---|---|
| Echocardiographic reverse remodeling responders · 12 months | 77.5% of 262 | 76.3% of 249 | P = 0.83 |
Individual components of the primary end point
- No significant differences, except lead complications related to RA functionality
6-minute walk test distance · 12 months
- Walking distance did not differ between 2 study arms (404 versus 398 m)
- P = 0.62
Safety
Lead complications related to right atrial functionality
P = 0.040
- Standard atrial lead implantation required (CRT-DX) · median follow-up 2.4 years
- 1 · events
Original publication
Role of Atrial Pacing Support in Cardiac Resynchronization Therapy: A Noninferiority Randomized Trial. Circulation. Published 30 March 2026. doi:10.1161/circulationaha.126.079859
Summarised from the published abstract; every number is checked against it