Atrioventricular Block, Second and Third Degree
Conditions
Keywords
Pacemaker, Transcatheter Aortic Valve Replacement, Conduction System Pacing (CSP), Atrioventricular Block, Congestive Heart Failure, Bradycardia
Brief summary
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Detailed description
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
Interventions
DEVICEconduction system pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
DEVICEright ventricular or biventricular pacing
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Sponsors
Medical Research Agency, Poland
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
Intervention model description
Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF \<40%, following current ESC guidelines.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation 2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines 3. Written informed consent 4. Age of at least 18 years
Exclusion criteria
1. Permanent pacemaker implantation before TAVI procedure 2. The occurrence of conduction disturbances more than 30 days after TAVI procedure 3. No written informed consent 4. Inability to obtain informed consent from participant 5. Predicted inability to obtain cooperation from patient during observation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Hospitalization | 12 months | Hospitalization due to heart failure as a main reason |
| All-cause death | 12 months | Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pacing-Induced Cardiomyopathy (PICM) | 24 months | Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by \>=10% to the absolute value of \<50% |
| Change in global longitudinal strain (GLS) | 24 months | An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%. |
| Atrial Fibrillation (AF) episodes | 24 months | Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF). |
| Change in exercise capacity | 24 months | Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more |
| Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP) | 24 months | pl/mL |
| Change in Quality of Life | 24 months | Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome. |
| Atrial High Rate Episodes (AHRE) in pacemaker recordings | 24 months | Occurrence or change of the burden of AHRE events in the records from the CIED. |
| Response to Cardiac Resynchronization Therapy (CRT) | 24 months | Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values |
Countries
Poland
Contacts
Primary ContactKrzysztof S. Gołba, MD PhD
Backup ContactTomasz Soral, MD
Outcome results
None listed