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NCT07531368Toborzás még nem indult

BBAP With CS Mapping Guidance

Efficacy and Safety of Atrial Lead Placement Targeting Bachmann's Bundle Under Guidance of Left Atrial Potential Mapping Via the Coronary Sinus for Cardiac Resynchronization Therapy Pacing

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 15.

Rövid összefoglaló (regiszter, angolul)

Study Title Efficacy and Safety of Coronary Sinus-Based Left Atrial Mapping for Guiding Atrial Lead Implantation Targeting Bachmann Bundle Capture in Cardiac Resynchronization Therapy Research Objectives This study intends to use a 10-pole coronary sinus (CS) catheter to map left atrial activation time, assist in identifying the Bachmann bundle (BB) region, and further guide Bachmann bundle atrial pacing (BBAP) lead implantation. The anatomical relationship between the lead and the Bachmann bundle will be displayed by postoperative computed tomographic angiography (CTA), thereby verifying the efficacy and safety of this method in guiding BBAP surgical operations. Study Endpoints Primary Endpoint * Technical success rate Key Secondary Endpoints * Procedure time② Radiation dose③ Number of attempts for atrial lead screw-in during the operation: cumulative number of atrial lead implantation attempts during the operation④ Lead repositioning/reoperation rate⑤ Changes in electrical parameters (pacing threshold, lead impedance, intracardiac sensing) of the atrial lead at immediate postoperative, 1-month, 3-month, 6-month, 9-month, and 12-month follow-up⑥ Comparison of the effects of BBAP and right atrial appendage pacing (RAAP) on acute intraoperative hemodynamics⑦ Comparison of the differences in atrial high-rate (AHR) response in pacemaker programming data between BBAP and RAAP during 1-month, 3-month, 6-month, 9-month, and 12-month follow-up Safety Endpoints * Major safety endpoint: Composite of severe complications② Minor safety endpoint: Incidence of specific adverse events Exploratory Endpoints Health economics, electrophysiological indicators Secondary Efficacy Endpoints To be further clarified according to the study design and clinical data collection. Revisions Summary Full expansion of all abbreviations on first occurrence CS = coronary sinus BB = Bachmann bundle BBAP = Bachmann bundle atrial pacing CTA = computed tomographic angiography RAAP = right atrial appendage pacing AHR = atrial high-rate Minor wording \& clarity improvements Specified "pacing threshold, lead impedance, intracardiac sensing" for clearer electrical parameter description Spelling/typo check No spelling errors, typos, or grammatical issues identified in the original text Consistent terminology maintained throughout

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tervezett)
Első benyújtás
2026. márc. 15.
Kezdés
2026. máj. 1.
Elsődleges befejezés
2027. dec. 31.
Fő szponzor
Shanghai Zhongshan Hospital
NCT-szám
NCT07531368

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 40
  • 2026. máj. 1. és az elsődleges befejezés (2027. dec. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Prior implantation of CRT/ICD/pacemaker: Previous implantation of any cardiac implantable electronic device (CIED), except for patients in Group C requiring device replacement/upgrade
  • Recent cardiovascular events: Acute myocardial infarction, stroke/transient ischemic attack (TIA) within 3 months before enrollment; coronary revascularization (PCI or CABG) within 6 months before enrollment

Más betegség

  • Non-compliance with GDMT requirements: Failure to receive or inability to tolerate optimized medical therapy
  • Severe valvular heart disease: Severe aortic stenosis/regurgitation, mitral stenosis requiring surgical or interventional treatment
  • Unstable angina pectoris: Canadian Cardiovascular Society (CCS) class III-IV
  • Severe arrhythmias: History of sustained ventricular tachycardia or ventricular fibrillation (without ICD protection)
  • Active infection: Including sepsis, infective endocarditis, etc.
  • Malignant tumor: Advanced malignant tumor with expected survival \< 12 months
  • Cognitive impairment: Inability to provide informed consent or follow the study protocol
  • Mental illness: Severe mental disorders affecting treatment compliance
  • Venous access disorders: Inability to implant CRT via venous route (e.g., bilateral subclavian vein occlusion)
  • Participation in other interventional clinical trials, or other conditions deemed unsuitable for enrollment by the investigator

Laborértékek

  • Excessive improvement in LVEF: Recent (within 3 months) LVEF \> 40% with clear evidence of normalized cardiac function
  • Severe renal insufficiency: Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m² or uncontrolled renal failure

Életkor

  • Pregnancy or lactation: Positive pregnancy test in women of childbearing age or planned pregnancy

Egyéb

  • Inappropriate QRS duration: QRS \< 130 ms (Groups A and C)
  • Types of cardiomyopathy: Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), and other specific etiologies not suitable for CRT
  • Severe liver dysfunction: Child-Pugh class C
  • Geographical restrictions: Inability to maintain contact or return to the medical center regularly during follow-up
  • Contralateral device: Implanted contralateral CIED leading to risk of lead crossing or interference

Kiket keres a vizsgálat

  • \- 1 Sinus rhythm
  • 2 Left ventricular ejection fraction (LVEF) ≤ 35%, QRS duration ≥ 150 ms; or 130 ms \< QRS duration \< 150 ms with left bundle branch block (LBBB) morphology
  • 3 LVEF ≤ 40% with expected ventricular pacing \> 20%
  • 4 New York Heart Association (NYHA) class II, III, or ambulatory IV symptoms
  • 5 After at least 3 months of guideline-directed medical therapy (GDMT) optimization
  • 6 Age ≥ 18 years
  • 7 Signed informed consent form, good compliance, and ability to complete study follow-up

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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