What side effects are associated with this type of intervention?

Common treatments for Congestive Heart Failure (CHF) include cardiac resynchronization therapy (CRT) and pharmacologic agents like beta-blockers, ACE inhibitors, and diuretics. CRT, including devices with SyncAV ON programming, can cause infection at the implantation site, lead dislodgement, and device malfunction. Beta-blockers may lead to fatigue, bradycardia, and hypotension. ACE inhibitors can cause cough, hyperkalemia, and renal dysfunction. Diuretics often result in electrolyte imbalances and dehydration. Careful monitoring is essential to manage these side effects effectively.

What prior FDA approvals exist?

FDA-approved treatments for Congestive Heart Failure (CHF) include Cardiac Resynchronization Therapy (CRT) devices, which improve heart synchronization and enhance left ventricular (LV) reverse remodeling. These devices optimize the timing of electrical impulses to improve cardiac efficiency. The SyncAV ON programming mode in CRT devices is an advanced feature that further refines this synchronization. Other approved treatments for CHF include medications like beta-blockers, ACE inhibitors, and ARBs, which help manage symptoms and improve heart function.

What other types of research exist?

Promising novel alternatives to SyncAV ON Programming Mode in CRT devices for CHF patients include: 1) MultiPoint Pacing (MPP), which delivers pacing from multiple sites within the left ventricle to improve cardiac resynchronization; 2) His-bundle pacing, which directly stimulates the His bundle to achieve more physiological ventricular activation; and 3) Adaptive CRT, which automatically adjusts pacing parameters based on real-time cardiac activity to optimize therapy. These alternatives have shown potential in enhancing LV reverse remodeling and improving clinical outcomes in CHF patients.

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Cardiac Resynchronization Therapy Device

SyncAV CRT Programming for Heart Failure (SyncAV Trial)

N/A

Waitlist Available

Led By Niraj Varma, MD

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria:

Be older than 18 years old

Must not have

Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period

Prior His Bundle pacing implant or plan to have His Bundle pacing implant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following trial randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special setting in heart devices called SyncAV ON to help patients with new heart devices. It aims to improve how well their hearts pump blood by adjusting the timing of electrical signals in the heart.

Who is the study for?

This trial is for adults with heart failure who have a specific ECG pattern, intact AV conduction, and are on optimal heart failure medication. They must be getting a new CRT device or upgrading to an Abbott CRT system without prior LV lead placement. Exclusions include recent heart issues, stroke, certain procedures within the last few months, persistent AF, pregnancy, limited life expectancy or other conflicting clinical trials.

What is being tested?

The SyncAV Post-Market Trial tests if setting CRT devices to 'SyncAV ON' improves heart function better than traditional fixed AV delay settings by observing changes in the left ventricle's size and function over time.

What are the potential side effects?

While not explicitly listed here, side effects may include typical risks associated with CRT device implantation such as infection at the site of surgery, bleeding complications or issues related to improper pacing like dizziness or palpitations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a new or upgraded CRT device implant without prior LV lead placement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart transplant or am considered a top priority for one.

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I have or will have a His Bundle pacing device implanted.

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I have had or plan to have heart vessel repair surgery recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following trial randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following trial randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following trial randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months

Secondary study objectives

Percentage of CRT Responders at 12 months

Percentage of female subjects classified as CRT Responders at 12 months

Reduction in LVESV in female subjects between baseline and 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SyncAV ArmExperimental Treatment1 Intervention

Treatment Arm

Group II: Fixed AV Delay ArmActive Control1 Intervention

Control Arm

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Congestive Heart Failure (CHF) include pharmacologic therapies such as beta-blockers, ACE inhibitors, and ARBs, which help reduce the heart's workload and prevent further damage. Cardiac resynchronization therapy (CRT) devices, particularly those with SyncAV ON programming, optimize the timing of electrical impulses to improve heart muscle synchronization and enhance left ventricular (LV) reverse remodeling. This improved synchronization is vital for CHF patients as it enhances cardiac efficiency, reduces symptoms, and improves overall heart function and quality of life.