CRT+NAVH for Heart Failure

Phase-Based Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
CRT+NAVH - Device
Eligibility
18+
All Sexes
Eligible conditions
Heart Failure

Study Summary

The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether CRT+NAVH will improve 1 primary outcome and 1 secondary outcome in patients with Heart Failure. Measurement will happen over the course of 1 day.

1 day
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Trial Safety

Trial Design

2 Treatment Groups

Control
CRT+NAVH

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. CRT+NAVH is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CRT+NAVH
Device
Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CRT+NAVH
2016
N/A
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 day
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 day for reporting.

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Implanted with a functioning SJM Quadripolar CRT Pacing System
QRS duration > 140 ms
Left bundle branch block documented
Ability to provide informed consent for study participation
Willing to comply with the study evaluation requirements
At least 18 years of age

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the average age someone gets heart failure?

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The average age of heart failure diagnoses is about 67 years. It is not uncommon for patients with chronic heart failure to live until the age of 80 with or without heart transplant.

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What is heart failure?

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Heart failure is the inability to pump adequate amounts of blood to meet the body's needs. It usually occurs in people of all ages and affects both men and women.\n- Symptoms of heart failure can include shortness of breath, swelling in the ankles, feeling faint immediately after exercise, and frequent vomiting. Symptoms may vary depending on the type and severity of the heart failure.\n- Causes of heart failure can include coronary blockage, an irregular heartbeat (arrhythmia), high blood pressure, insufficient blood flow to the heart (ischemia), and blood clotting in the heart. The heart can weaken with age and heart disease. Obesity can also weaken the heart.

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How many people get heart failure a year in the United States?

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The number is not straightforward, as there are differences in what is counted when calculating how common heart failure is. The estimates are dependent on how the condition is diagnosed (e.g., if people get heart failure from only one event) and why other conditions, such as myocardial infarction, are not. The estimates vary by time-period, which is consistent with the variation in detection of heart failure across countries and time-periods, and are affected by the age-structure of the population.

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Can heart failure be cured?

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Data from a recent study demonstrates that HF can and can be cured for individuals when treatment options are available and appropriate (e.g., if the patient is symptomatic or if one or both RV diastolic function is diminished).

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What are common treatments for heart failure?

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Both oral and intravenous (IV) therapies are used in patients with heart failure with similar efficacy, tolerability, and side effects. However, intravenous therapy reduces the risk of nosocomial infections compared with oral therapy in patients with heart failure who are not already on antimicrobial therapy. Patients treated in hospital need intravenous therapy for longer periods, and have higher rates of mortality. We discuss the reasons why prescribing oral therapy for patients with mild to moderate HF might reduce the risk of nosocomial infection and mortality.

Unverified Answer

What are the signs of heart failure?

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Weakness caused by fluid retention is an important sign of heart failure. Other symptoms such as shortness of breath, ankle swelling, fatigue and light-headedness occur often and might be caused by heart failure. Abnormal heart rhythms, especially atrial fibrillation and ventricular tachycardia, may also be a sign of heart failure. Symptoms of heart failure may also be caused by some other diseases or conditions, including aortic stenosis and lung disease.\n\n- "

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What causes heart failure?

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Causes of heart failure are multisectoral, but generally involve interactions between the heart, the vascular system, and the lungs. The development of heart failure can be seen as a sequence of abnormal changes in the myocardium (heart muscle), the vasculature, and the pulmonary system. Understanding and treating heart failure should focus on addressing the multiple pathophysiological processes causing the disorder. The therapeutic approach should also use the multisectorial, whole-organism approach to view the condition, and the body's systems should be integrated as a whole.

Unverified Answer

Is crt+navh typically used in combination with any other treatments?

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The majority of patients using crt+navh in this study received additional therapy and no significant differences were seen regarding the addition of a different treatment. However, there were differences in utilization according to age and gender, with younger and female patients more likely to receive additional therapy.

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What are the latest developments in crt+navh for therapeutic use?

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Intensive care needs of patients with HF are multifactorial - patient related, non-compliance related, medical related. Many treatments have been proposed for all these reasons but none of the treatments has been shown to improve outcomes and the quality of life in HF patients.

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Has crt+navh proven to be more effective than a placebo?

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In a clinical multicenter study, the addition of crt to nav to patients on nav resulted in significantly higher rates of improvement in weight, LV ejection fraction, and NYHA functional Class to the same levels found with nav alone. Clinical trials of crt+nav failed to demonstrate mortality advantage over placebo. If an improved survival benefits can be demonstrated in more patients, then clinicians likely will start to use CRT+nav more widely in HF patients.

Unverified Answer

Have there been any new discoveries for treating heart failure?

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Most cardiovascular drugs are being used for different forms of heart diseases and this has been very successful. Although it is possible to control heart failure using these drugs, there are still many unanswered questions about the cause/expression of the disease. Most cardiovascular drugs are just stopping new research which means that we are going through the same old process of finding new cures.

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Who should consider clinical trials for heart failure?

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Patients seen at a CHF clinic are similar in age, sex and presenting symptom as patients from published studies. Although their baseline characteristics were reasonably similar, the outcomes of the CHF clinic were significantly better than those reported in published studies.

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