Active — Not RecruitingNot Applicable

Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block

China683 participantsStarted 2021-06-22

Plain-language summary

OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years. An LBBP group will be compared with a group of conventional RVP in the follow-up of at least 3 years. The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in patients with AV block.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms
✓. LVEF \> 35%, NYHA classification I-III
✓. Age \> 18 years
✓. Signed informed consent

Exclusion criteria

✕. Implanted prosthetic tricuspid valve
✕. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
✕. Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months
✕. Enrolled in any other study
✕. A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons
✕. Pregnant or with a child-bearing plan
✕. A history of heart transplantation
✕. Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect

What they're measuring

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 6-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 12-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 24-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 36-month follow-up

Trial details

NCT IDNCT04624763

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Atrioventricular Block trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms
✓. LVEF \> 35%, NYHA classification I-III
✓. Age \> 18 years
✓. Signed informed consent

Exclusion criteria

✕. Implanted prosthetic tricuspid valve
✕. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
✕. Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months
✕. Enrolled in any other study
✕. A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons
✕. Pregnant or with a child-bearing plan
✕. A history of heart transplantation
✕. Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect

What they're measuring

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 6-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 12-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 24-month follow-up

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

Timeframe: 36-month follow-up