Safety, feasibility and efficacy of CRT-D with left bundle branch area pacing lead - SAFE DEAL trial

Safety, feasibility and efficacy of CRT-D with left bundle branch area pacing lead - SAFE DEAL trial - SAFE DEAL trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039957

Enrollment

Registered

2026-04-22

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.1

Interventions

Group 1: Use of a left bundle branch area pacing (LBBAP) lead instead of a coronary sinus lead in CRT-D devices. Followup after Implantation, after 3, 6 and 12 months.

Eligibility

Sex/Gender

All

Age

19 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Guideline based indication for cardiac resynchronization and implanted defibrillator therapy 2) LVEF =35% 3) Complete left bundle branch block QRS duration =130 ms 4) NYHA II-III 5) Age >18 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Planned coronary revascularization or transcatheter aortic valve implantation (TAVI) 2) Life expectancy of less than 3 years 3) Pregnancy 4) Patient is unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
1. Development of left ventricular ejection fraction from baseline to 6 months 2. Serious adverse device effect (SADE) free rate after 6 months of follow up	—

Secondary

Measure	Time frame
1. SADE-free rate at 12-months follow-up 2. Development of left ventricular ejection fraction from baseline to 3 months 3. Development of left ventricular ejection fraction from baseline to 12 months 4. Success rate of meeting the LBBAP Criteria 5. Quality of life questionnaire 6. Identification of baseline characteristics predicting successful implantation 7. Identification of baseline characteristics predicting successful LBBAP criteria 8. Hospitalization for heart failure 9. All-cause mortality 10. Upgrade to cardiac resynchronization (CRT) therapy 11. Change in NYHA functional class	—

Measure

Time frame

1. SADE-free rate at 12-months follow-up 2. Development of left ventricular ejection fraction from baseline to 3 months 3. Development of left ventricular ejection fraction from baseline to 12 months 4. Success rate of meeting the LBBAP Criteria 5. Quality of life questionnaire 6. Identification of baseline characteristics predicting successful implantation 7. Identification of baseline characteristics predicting successful LBBAP criteria 8. Hospitalization for heart failure 9. All-cause mortality 10. Upgrade to cardiac resynchronization (CRT) therapy 11. Change in NYHA functional class

—

Countries

Germany

Contacts

Public ContactPatrick Schurr

Uniklinik Freiburg - Universitäts- Herzzentrum Freiburg- Bad Krozingen, Standort Bad Krozingen

patrick.schurr@uniklinik-freiburg.de0049 7633 402 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026