Acute Effects of LBBP Versus BVP for CRT

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04505384
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Cardiac Pacing, Artificial; Cardiac Resynchronization Therapy	Procedure: left bundle branch pacing; Procedure: biventricular pacing	N/A

Detailed Description

The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left bundle branch pacing Left bundle branch pacing	Procedure: left bundle branch pacing; left bundle branch pacing
Active Comparator: Biventricular pacing Biventricular pacing	Procedure: biventricular pacing; biventricular pacing

Outcome Measures

Primary Outcome Measures

1. Hemodynamic parameter LV dP/dt(max) [1 hour]

   LV dP/dt(max) will be obtained during implant procedure.

Secondary Outcome Measures

1. Electrical synchrony parameters including QRS duration and QRS area [0.5 hour]

   Acquired from EP system during procedure

2. Mechanical parameters including Ts-SD and IVMD [0.5 hour]

   Acquired by an echocardiologist during procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• NYHA class II-IV;

• LVEF <=35%;

• LBBB with QRS duration >=130ms.

Exclusion Criteria:

• moderate-to-severe aortic stenosis;

• frequent premature ventricular complexes;

• significant peripheral vascular disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	180 Fenglin Road	Shanghai		China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

• Study Chair: Yangang Su, MD, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT04505384
• Other Study ID Numbers: ZS-LBBPvsBVP
• First Posted: Aug 10, 2020
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 20, 2022