Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant

New heart rhythm therapy tested against standard treatment for heart failure

NCT: NCT06105580 · Status: RECRUITING · Phase: N/A · Sponsor: Hospital Clinic of Barcelona · Started: 2023-11-27 · Est. Completion: 2028-01

Plain English Summary

Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant is a Not Applicable clinical trial sponsored by Hospital Clinic of Barcelona studying Cardiac Resynchronization Therapy, Heart Failure. This trial tests a new way to pace the heart called conduction system pacing against a standard treatment called biventricular pacing. It is for adults with heart failure and a specific type of electrical problem in their heart (wide QRS). Participants will be randomly assigned to receive either the new pacing or the standard pacing, and will be followed for one year. The standard treatment for this condition is biventricular pacing. The trial aims to enroll 320 participants.

Official Summary

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial). Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with heart failure and a weakened heart pump (low ejection fraction). Patients must have a specific heart rhythm issue called a left bundle branch block with a wide QRS, or other types of wide QRS. Patients with certain heart conditions or who have had a recent heart attack or procedure will not be able to join. Women who are pregnant will not be able to participate. This trial is studying Cardiac Resynchronization Therapy, Heart Failure, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the new pacing method reduces the risk of death, needing a heart transplant, or hospitalization for heart failure within one year. The specific primary outcome measures are: Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization. (1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to find a potentially better way to treat heart failure by improving how the heart's electrical system works, addressing a gap in current therapies. This research targets Cardiac Resynchronization Therapy, Heart Failure, where improved treatment options are needed.

Investor Insight

This trial addresses a significant market for heart failure devices, with the potential to establish a new standard of care if successful, indicating a strong investment signal.

Is This Trial Right for Me?

Ask your doctor if conduction system pacing is a suitable option for your heart condition. Participation involves receiving a heart pacing device and attending regular follow-up appointments for a year. You will have regular check-ups, including heart tests, to monitor your progress. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Patient must indicate acceptance to participate in the study by signing an informed consent document.
* Patient must be ≥ 18 years of age.
* Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
* Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
* Resynchronization therapy indication for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
* LVEF \<=35% in NYHA class III or IV, atrial fibrillation and intrinsic QRS \>=130 ms, provided a strategy to ensure biventricular capture is in place.

Exclusion Criteria:

* Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
* Pregnancy.
* Participating currently in a clinical investigation that includes an active treatment.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06105580?

NCT06105580 is a Not Applicable INTERVENTIONAL study titled "Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant." It is currently recruiting and is sponsored by Hospital Clinic of Barcelona. The trial targets enrollment of 320 participants.

What conditions does NCT06105580 study?

This trial investigates treatments for Cardiac Resynchronization Therapy, Heart Failure. The primary condition under study is Cardiac Resynchronization Therapy.

What treatments are being tested in NCT06105580?

The interventions being studied include: Conduction system pacing (PROCEDURE), Biventricular pacing (PROCEDURE). Conduction system pacing implant as a Resynchronization therapy.

What does Not Applicable mean for NCT06105580?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06105580?

This trial is currently "Recruiting." It started on 2023-11-27. The estimated completion date is 2028-01.

Who is sponsoring NCT06105580?

NCT06105580 is sponsored by Hospital Clinic of Barcelona. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06105580?

The trial aims to enroll 320 participants. The trial is currently recruiting and accepting new participants.

How is NCT06105580 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06105580?

The primary outcome measures are: Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization. (1 year). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06105580 being conducted?

This trial is being conducted at 1 site, including Barcelona (Spain).

Where can I find official information about NCT06105580?

The official record for NCT06105580 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06105580. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06105580 testing in simple terms?

This trial tests a new way to pace the heart called conduction system pacing against a standard treatment called biventricular pacing. It is for adults with heart failure and a specific type of electrical problem in their heart (wide QRS).

Why is this trial significant?

This trial aims to find a potentially better way to treat heart failure by improving how the heart's electrical system works, addressing a gap in current therapies.

What are the potential risks of participating in NCT06105580?

Potential risks include those associated with any heart device implantation, such as bleeding, infection, or device malfunction. Some patients may experience discomfort or pain at the implant site. The new pacing method might not be as effective as the standard treatment for some individuals. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06105580?

Ask your doctor if conduction system pacing is a suitable option for your heart condition. Participation involves receiving a heart pacing device and attending regular follow-up appointments for a year. You will have regular check-ups, including heart tests, to monitor your progress. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06105580 signal from an investment perspective?

This trial addresses a significant market for heart failure devices, with the potential to establish a new standard of care if successful, indicating a strong investment signal. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either the new pacing or the standard pacing, and will be followed for one year. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.