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The utility of an additional pacing wire on the left side of the heart in patients who are undergoing pacemaker implantation for heart failure i.e. Cardiac Resynchronization Therapy

Left Bundle Branch Area Pacing versus Left Bundle Optimised Cardiac Resynchronization Therapy in patients with Non Ischemic Cardiomyopathy and Left Bundle Branch Block - A Crossover Study / Randomized Controlled Trial - LOT-CRT vs LBBAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045773
Enrollment
40
Registered
2022-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: I502- Systolic (congestive) heart failure

Interventions

Intervention1: Left Bundle optimised Cardiac Resynchronization Therapy (LOT-CRT): Pacing from both the left bundle lead and coronary sinus lead implanted transvenously into the heart, for 6 months Con

Sponsors

Dr Chinmay Parale
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age more than 18 years 2.Non ischemic cardiomyopathy (Cardiomyopathy with normal coronaries on an angiogram) 3.NYHA class II-IV symptoms (Ambulatory class IV) 4.LVEF less than or equal to 35 percent 5.Left bundle branch block with QRS duration more than 130 msec 6.Sinus rhythm 7.On optimal medical management for heart failure for at least three months 8.Successful implantation of the coronary sinus (CS) lead and left bundle branch area (LBA) lead

Exclusion criteria

Exclusion criteria: 1.Patients with non-ambulatory class IV heart failure and hypotension requiring persistent inotropes 2.Patients with a serum creatinine level of more than 3.0 mg/dl 3.Patients with a primary mitral valvular pathology causing moderate or severe mitral regurgitation

Design outcomes

Primary

MeasureTime frame
QRS width and LV ejection fraction (LVEF) Timepoint: 2 days and 6 months respectively—

Secondary

MeasureTime frame
Repolarization parameters (QTc, QT dispersion, T peak to T end interval) on ECGTimepoint: 2 days;Echocardiographic parameters (LV pre-ejection interval , Interventricular mechanical delay, TVI, dP/dt, LVEF)Timepoint: 2 days;Responder rateTimepoint: 6 months;ECG parameters (QRS width, QTc, QT dispersion, T peak to T end interval)Timepoint: 6 months;Echocardiographic parameters (LV Ejection fraction, LV end systolic volume, global longitudinal and circumferential strain, degree of mitral regurgitation)Timepoint: 6 months—

Countries

India

Contacts

Public ContactChinmay Parale

Jawaharlal Institute of Postgraduate Medical Education and Research

rajajs@gmail.com9442242648

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026