Baseline Atrial Fibrosis for Predicting Post-Operative Atrial Fibrillation

Recruiting at 3 trial locations

Overseen By Chris Wang, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Atrial arrhythmia, Cardiac surgery, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the condition of the left atrial wall in the heart affects the risk of developing atrial arrhythmias (irregular heartbeats) after cardiac surgery. Researchers believe that more scarring in this part of the heart may increase the likelihood of irregular heartbeats and other complications, such as longer hospital stays and higher costs. Suitable candidates for this trial are individuals over 40 years old who have never experienced irregular heartbeats and are scheduled for specific heart surgeries, such as bypass or valve repair. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future cardiac care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for cardiac surgery?

Studies have shown that heart surgery is generally safe and well-tolerated. In one large study, 94.6% of patients went home the day after surgery, indicating quick recovery for most. Another study found a low risk of major complications or death during surgery.

Research over the years has improved the chances of a good outcome. For example, the risk of dying from heart surgery decreased significantly, from 3.3% in 2007 to just 1.1% in 2019, demonstrating increased safety over time.

Long-term studies confirm that certain types of heart surgery remain effective and safe, especially for younger patients. Overall, evidence suggests that heart surgery is a well-accepted treatment with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to understand how baseline atrial fibrosis can predict the risk of post-operative atrial fibrillation (AF) in patients undergoing cardiac surgery. This approach is unique because it seeks to personalize risk assessment, potentially allowing for better preventative strategies tailored to individual patients. By focusing on the condition of atrial fibrosis, the study could lead to more precise interventions that improve outcomes and reduce the occurrence of AF after surgery, setting it apart from current one-size-fits-all approaches.

What evidence suggests that cardiac surgery could be effective for atrial arrhythmias?

Research has shown that heart surgery greatly improves patient outcomes, with death rates within a year dropping to about 5.1% in some studies. Over the years, deaths from adult heart surgery have decreased significantly, from 3.3% in 2007 to just 1.1% in 2019. This trend indicates that heart surgery is becoming safer and more effective. Many patients report feeling better and experiencing an improved quality of life after surgery, underscoring the procedure's positive impact. While heart surgery addresses many heart problems, its success in treating specific issues like irregular heartbeats after surgery (known as post-operative atrial fibrillation) remains under study. This condition may be influenced by other factors, such as changes in heart tissue. ^{4 6 7 8 9}

Who Is on the Research Team?

Nassir Marrouche, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female patients age 40 years of age or older

Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair/reconstruction, aneurysm repair, and insertion of pacemaker).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Assessment

Baseline MRI is performed to assess atrial fibrosis and assign Utah stages

1 week

1 visit (in-person)

Surgery and Immediate Post-operative Monitoring

Patients undergo cardiac surgery and are monitored for atrial arrhythmias using telemetry and ECG

2 weeks

Continuous in-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of complications and hospital costs

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Surgery

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8965735/

Effect of Cardiac Surgery on One-Year Patient-Reported ... One-year all-cause mortality was 5.1% (5 of 98). Rate of major morbidity was 11.2% (11 of 98). Cardiac surgery significantly improved patient-reported outcomes ...

2. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/cardiothoracic-surgical-outcomes-what-steady-improvements-add-up-to-over-time

Cardiothoracic Surgical Outcomes: What Steady ... - Consult QD For adult cardiac surgery, mortality has been slashed by two-thirds, from 3.3% in 2007 to 1.1% in 2019. Thoracic surgery mortality dropped even ...

3. uclahealth.org uclahealth.org/news/article/cardiac-surgery-consortium-leverages-data-improved-clinical

Cardiac surgery consortium leverages data for improved ... Clinical outcomes in isolated coronary artery bypass grafting (CABG), the most common procedure, showed improved early extubation, reduced blood ...

4. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(23)00008-5/fulltext

2022 Update on Outcomes and Research This report encompasses data from the years 2020 and 2021 and is the seventh in a series of reports that provide updated volumes, outcomes, ...

5. publicreporting.sts.org publicreporting.sts.org/

STS Public Reporting: Homepage Using this information, consumers can see how participating cardiac surgical groups compare with national benchmarks for overall performance, survival, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40676729/

Assessing the Safety, Feasibility, and Clinical Outcomes of ... In total, 94.6% (n = 2649) of patients were discharged the day after surgery. Of those requiring ICU care (n = 152), circulatory failure (n = 57) ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.011065

Multicenter Analysis of the Relationship Between Operative ... The primary outcomes were (1) safety, measured by the STS' composite major morbidity and operative mortality measure, and (2) procedural ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0003497525002218

The Society of Thoracic Surgeons Adult Cardiac Surgery ... Thourani and colleagues reported an 8-year survival of 87.6% after AVR in a low-risk contemporary cohort of 42,586 patients, whereas Sabik and colleagues ...

9. cardiovascularbusiness.com cardiovascularbusiness.com/topics/clinical/cardiac-surgery/long-term-data-highlight-ross-procedures-safety-effectiveness-younger-patients

Long-term data highlight Ross procedure's safety, ... Long-term outcomes data for patients undergoing the Ross procedure confirm that it is an effective treatment option for younger patients, ...