Purpose of this Study
The SYNCHRONICITY study is a test to compare two treatments for people with heart failure and a heart electrical problem called left bundle branch block. People in the study will be randomly chosen to get one of two devices: a new type called LBBAP or a regular type called CRT. First, they will have surgery to put in the device. Then, they will have checkups at 6 months, 12 months, and once a year for up to 5 years. At these visits, doctors will check the device, do heart tests, and ask how the person feels. The study wants to find out which device is safer and works better.
Who Can Participate?
Eligibility
To join the SYNCHRONICITY study, people must be at least 18 years old and agree to take part. They need to have heart failure with a very weak heart pump and symptoms like tiredness or trouble breathing, even after taking heart medicine for 3 months. They must also have a heart rhythm problem called left bundle branch block, shown on a heart test called an ECG. They need to qualify for a special heart device called CRT-D and another device to prevent dangerous heart rhythms. Finally, they must agree to come to all study visits and use remote monitoring.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The SYNCHRONICITY study wants to learn if a new way to help the heart beat, called left bundle branch area pacing (LBBAP), is safe and works well. This new method will be compared to the usual treatment called cardiac resynchronization therapy (CRT). The study is for people who have heart failure and an electrical problem in their heart. The goal is to see if LBBAP can help people live longer and feel better.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Safety and Effectiveness of Left Bundle Branch Area Pacing versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Principal Investigator
Daniel
Friedman
Protocol Number
PRO00118920
NCT ID
NCT07069738
Phase
III
Enrollment Status
Pending Open to Enrollment