Atrioventricular Block Clinical Trial
Official title:
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (>40%).
Status | Recruiting |
Enrollment | 450 |
Est. completion date | November 1, 2026 |
Est. primary completion date | November 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. At least 19 years old and willing and capable to give informed consent 2. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (>40%) is anticipated Exclusion criteria: 1. Incapacitated or unable to read or write 2. Patient who is an indication of ICD or CRT 3. History of prosthetic valve surgery on tricuspid valve 4. Prior myocardial infarction including ventricular septum 5. Life expectancy < 12 months due to any condition 6. Unavailable for at least 24 months of follow-up visits 7. Pregnant or breastfeeding at the time of signing consent 8. Prior Heart transplant surgery 9. Persistent Left Superior Vena Cava (PLSVC) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Bucheon Sejong Hospital | Bucheon | |
Korea, Republic of | GyeongSang National University Changwon Hospital | Changwon | |
Korea, Republic of | Chungbuk National University Hospital | Chungju | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Kyunghee University hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul Saint Mary's Hospital | Seoul | |
Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10. — View Citation
Curtis AB, Worley SJ, Adamson PB, Chung ES, Niazi I, Sherfesee L, Shinn T, Sutton MS; Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. 2013 Apr 25;368(17):1585-93. doi: 10.1056/NEJMoa1210356. — View Citation
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651. — View Citation
Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Mao G, Vijayaraman P, Ellenbogen KA. Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019 Jan;105(2):137-143. doi: 10.1136/heartjnl-2018-313415. Epub 2018 Aug 9. — View Citation
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Sharma PS, Patel NR, Ravi V, Zalavadia DV, Dommaraju S, Garg V, Larsen TR, Naperkowski AM, Wasserlauf J, Krishnan K, Young W, Pokharel P, Oren JW, Storm RH, Trohman RG, Huang HD, Subzposh FA, Vijayaraman P. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2022 Jan;19(1):3-11. doi: 10.1016/j.hrthm.2021.08.033. Epub 2021 Sep 3. Erratum In: Heart Rhythm. 2023 Jul;20(7):1100. — View Citation
Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2. — View Citation
Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006. — View Citation
Tse HF, Lau CP. Long-term effect of right ventricular pacing on myocardial perfusion and function. J Am Coll Cardiol. 1997 Mar 15;29(4):744-9. doi: 10.1016/s0735-1097(96)00586-4. — View Citation
Vijayaraman P, Ponnusamy S, Cano O, Sharma PS, Naperkowski A, Subsposh FA, Moskal P, Bednarek A, Dal Forno AR, Young W, Nanda S, Beer D, Herweg B, Jastrzebski M. Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group. JACC Clin Electrophysiol. 2021 Feb;7(2):135-147. doi: 10.1016/j.jacep.2020.08.015. Epub 2020 Oct 28. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy | All-cause death: including cardiovascular and non-cardiovascular deaths.
Heart failure hospitalization: An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy. Occurrence of Pacing induced cardiomyopathy : LVEF <50% and absolute LVEF decline =10% or increase in LVESV =15% Upgrade to cardiac resynchronization therapy (CRT): Upgrade from pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less). |
during 2 years after pacemaker implantation | |
Secondary | all cause mortality | All cause deaths including cardiovascular and non-cardiovascular deaths. | during 2 years after pacemaker implantation | |
Secondary | Cardiovascular mortality | Cardiovascular death | during 2 years after pacemaker implantation | |
Secondary | Heart failure hospitalization | An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy. | during 2 years after pacemaker implantation | |
Secondary | success rate of LBBAP implantation | LBBAP success is defined if ventricular lead is successfully placed at interventricular septum and RBB configuration observed during unipolar tip pacing. | during 3days after pacemaker implantation | |
Secondary | LBBAP related complications | Loss of lead function or need for lead revision, extraction, replacement for any reason | during 2 years after pacemaker implantation | |
Secondary | LBB capture failure | failed LBB capture, confirmed by investigator | during 2 years after pacemaker implantation | |
Secondary | Short-term procedure and Device related complications | composite of device and procedure related complications until 7 days after procedure | during 1wk after pacemaker implantation | |
Secondary | Long-term procedure and Device related complications | composite of device and procedure related complications after 7 days after procedure | during 1wk after pacemaker implantation | |
Secondary | Rate of LV systolic dysfunction | LVEF <50% and absolute reduction in LVEF >10%, and/or an increase in LVESV =15%. | 6month and 2yr after pacemaker implantation | |
Secondary | Changes in cardiopulmonary exercise test parameters | (VO2 peak, Exercise intensity, Peak Respiratory Exchange Ratio (Peak RER), Exercise time, age predicted aerobic capacity, VE/VCO2 slope, Lactate threshold, Max predicted HR, Max HR / Max predicted HR, presence of ST change , AF at Baseline, Incident AF during exercise | 6month and 2yr after pacemaker implantation | |
Secondary | Incidental atrial fibrillation | Newly developed atrial fibrillation in patients without documented atrial fibrillation | during 2 years after pacemaker implantation |
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