Heart Failure - NYHA II - IVSYNCHRONICITYNCT07069738
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
A study testing CRT-D with a Quadripolar LV lead and CRT-D with INGEVITY+ pace/sense lead in people with Heart Failure - NYHA II - IV, run by Boston Scientific Corporation at 43 sites in United States.
Trial summary
This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure - NYHA II - IV
- What is being tested?
- CRT-D with a Quadripolar LV lead and CRT-D with INGEVITY+ pace/sense lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 43 sitesUnited States
- Study dates
- 22 Oct 2025to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
- Patient meets a guideline-based indication for a de novo CRT-D device
- Primary prevention indication for ICD therapy
- Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)
- NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)* for at least 3 months
- GDMT is defined as all four drug classes listed below for at least 3 months prior to enrollment unless the investigator provides justification (e.g., contraindicated, not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI) Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol) Mineralocorticoid antagonists SGLT2 Inhibitor medications
Show all 10Show fewer
- Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment
- Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
- Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)
- Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)
Who cannot join
- Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
- Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment
- Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
- Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
- Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
- Prior or planned mechanical or bioprosthetic tricuspid valve replacement
Show all 21Show fewer
- Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
- Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
- History of heart transplantation or left ventricular assist device (LVAD) implantation
- Less than 1 year of life expectancy at the time of enrollment
- Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
- History of ventricular septal defect (VSD)
- Complex congenital heart disease
- Documented diagnosis of cardiac amyloidosis
- Known occlusion or other reason limiting central venous access for transvenous leads
- Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
- Patient currently requiring dialysis
- Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
- Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome
- Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.
Trial locations and contacts
43 sites in 1 country. Contact the study team or a site near you to ask about taking part.
43 sites in 1 country
United States43 sites, 40 recruiting
- Recruiting
Capital Cardiology Associates
Albany, New York, 12211
Rizwan Alimohammad, MD
Rizwan Alimohammad, MD
- Recruiting
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
Thomas Crawford, MD
Thomas Crawford, MD
- Recruiting
Piedmont Hospital
Atlanta, Georgia, 30309
Kavita Krishnasamy, MD
Kavita Krishnasamy, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Anand Shah, MD
Anand Shah, MD
- Recruiting
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
Navid Nafissi, MD
Navid Nafissi, MD
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Pamela Mason, MD
Pamela Mason, MD
- Recruiting
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Columbus, Ohio, 43214
Anish Amin, MD
Anish Amin, MD
- Recruiting
Mount Carmel Health System
Columbus, Ohio, 43219
Kamel Addo, MD
Kamel Addo, MD
- Withdrawn
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Daniel Friedman, MD
Daniel Friedman, MD
- Recruiting
Southcoast Physicians Group
Fall River, Massachusetts, 02720
Arnoldas Giedrimas, MD
Arnoldas Giedrimas, MD
- Recruiting
New York Hospital Queens
Flushing, New York, 11355
Seth Goldbarg, Dr.
Seth Goldbarg, Dr.
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49525
Jawad Wassim, MD
Jawad Wassim, MD
- Recruiting
University of Chicago
Hinsdale, Illinois, 60521
Shrinath Yeshwant, MD
Shrinath Yeshwant, MD
- Recruiting
Heart Center Research, LLC
Huntsville, Alabama, 35801
John Jennings, Dr.
John Jennings, Dr.
- Recruiting
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Krishna Malineni, MD
Krishna Malineni, MD
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Paari Dominic, MD
Paari Dominic, MD
- Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Devi Nair, Dr.
Devi Nair, Dr.
- Recruiting
Scripps Memorial Hospital
La Jolla, California, 92037
Nicolas Olson, MD
Nicolas Olson, MD
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Ashkan Ehdaie, MD
Ashkan Ehdaie, MD
- Recruiting
Baptist Hospital East Louisville
Louisville, Kentucky, 40207
Kevin Parrott, MD
Kevin Parrott, MD
- Recruiting
St. Luke's Idaho Cardiology Associates
Meridian, Idaho, 83642
Justice Oranefo, MD
Justice Oranefo, MD
- Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama, 36608
Ernest Matthew Quin, Dr.
Ernest Matthew Quin, Dr.
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07932
Michael Katz, MD
Michael Katz, MD
- Withdrawn
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
- Recruiting
St.Thomas Health
Nashville, Tennessee, 37205
Ricardo Lugo, MD
Ricardo Lugo, MD
- Recruiting
Weill Cornell Medical University
New York, New York, 10021
Jim Cheung, Dr.
Jim Cheung, Dr.
- Recruiting
Rochester General Hospital
New York, New York, 14621
Dmitry Chuprun, MD
Dmitry Chuprun, MD
- Recruiting
Alta Bates Summit Medical Center
Oakland, California, 94609
Rajan Shah, Dr.
Rajan Shah, Dr.
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
John Bullinga, MD
John Bullinga, MD
- Recruiting
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Mayank Sardana, MD
Mayank Sardana, MD
- Recruiting
Heart Hospital Baylor Plano
Plano, Texas, 75093
Mustafa Dohadwala, MD
Mustafa Dohadwala, MD
- Withdrawn
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
- Recruiting
Pacific Heart Institute
Santa Monica, California, 90404
Stephen Tang, MD
Stephan Tang, MD
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Antonio Moretta, Dr.
Antonio Moretta, Dr.
- Recruiting
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
Christopher Stanton, Dr.
Christopher Stanton, Dr.
- Recruiting
SUNY-Upstate Medical University
Syracuse, New York, 13057
Jorge Romero, MD
Jorge Romero, MD
- Recruiting
AdventHealth Tampa
Tampa, Florida, 33613
Kenneth Yamamura, MD
Kenneth Yamamura, MD
- Recruiting
Torrance Medical Center
Torrance, California, 90505
Gene Kim, MD
Gene Kim, MD
- Recruiting
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Stanislov Weiner, Dr.
Stanislov Weiner, Dr.
- Recruiting
Cardiology Associates Medical Group, Inc.
Ventura, California, 93003
Jonathan Dukes, Dr.
Jonathan Dukes, Dr.
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cyrus Hadadi, MD
Cyrus Hadadi, MD
- Recruiting
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18702
Pugazhendhi Vijayaraman, MD
Pugazhendhi Vijayaraman, MD
About this study
This study will compare two different methods to pace the heart to treat heart failure including:
- The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT).
- The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.
- Conditions
- Heart Failure - NYHA II - IV
- Being tested
- CRT-D with a Quadripolar LV lead, CRT-D with INGEVITY+ pace/sense lead
- Keywords
- Heart Failure, Conduction System Pacing, Primary Prevention, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-D with a Quadripolar LV leadDevice
Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
CRT-D with INGEVITY+ pace/sense leadDevice
Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA)
| Study group | Role | What they receive |
|---|---|---|
| CRT Cohort | Active comparator | Participants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort. Receives: Device: CRT-D with a Quadripolar LV lead |
| LBBA Cohort | Experimental | Participants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort. Receives: Device: CRT-D with INGEVITY+ pace/sense lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
Measured: Through study completion, up to maximum of 5 years
System-related complication-free rate
The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal
Measured: 12 months
Secondary outcomes (3)
Win ratio composite assessment
Win Ratio Ranking: 1) Death 2) Heart Transplant/LVAD 3) Number of Heart Failure (HF) events (includes in-patient, out-patient and HF re-admission 4) Number of VT/VF episodes requiring device therapy or external defibrillation/cardioversion (one episode per 24 hours 5) Change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) quality of life
Measured: Through study completion, up to a maximum of 5 years
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
Measured: Through study completion, up to a maximum of 5 years
System-related complication-free rate between randomized arms
System-related complication-free rate of LBBAP at 12 months. This will compare the two randomized arms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start22 Oct 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure - NYHA II - IVStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069738
- Sponsor's protocol ID
- C2403
- Acronym
- SYNCHRONICITY
- Status last verified
- Nov 2026
- First submitted
- 23 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT07069738
- Acronym / sponsor ID
- SYNCHRONICITY / C2403
- Conditions
- Heart Failure - NYHA II - IV
- Keywords
- Heart Failure, Conduction System Pacing, Primary Prevention, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two different methods to pace the heart to treat heart failure including:
- The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT).
- The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT Cohort | Active comparator | Device: CRT-D with a Quadripolar LV leadParticipants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort. |
| LBBA Cohort | Experimental | Device: CRT-D with INGEVITY+ pace/sense leadParticipants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
- Patient meets a guideline-based indication for a de novo CRT-D device
- Primary prevention indication for ICD therapy
- Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)
- NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)* for at least 3 months
Key exclusion criteria (21 listed)
- Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
- Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment
- Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
- Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
- Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-D with a Quadripolar LV leadParticipants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead. | Device | CRT Cohort |
| CRT-D with INGEVITY+ pace/sense leadParticipants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA) | Device | LBBA Cohort |
Primary outcome
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
Time frame: Through study completion, up to maximum of 5 years
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
System-related complication-free rate
Time frame: 12 months
The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal
3 secondary outcomes
Win ratio composite assessment
Time frame: Through study completion, up to a maximum of 5 years
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
Time frame: Through study completion, up to a maximum of 5 years
System-related complication-free rate between randomized arms
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-D with a Quadripolar LV lead and CRT-D with INGEVITY+ pace/sense lead in people with Heart Failure - NYHA II - IV, run by Boston Scientific Corporation at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Beaulieu (1-800-227-3422, jacqueline.beaulieu@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. (time frame: Through study completion, up to maximum of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.