Personalized pacemaker rate setting to improve symptoms in heart failure with bradycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares an individualized, hemodynamically optimized pacemaker lower rate to a conventional lower rate of 60 bpm in patients with heart failure and symptomatic bradycardia. Patients are randomized 1:1; the optimized group undergoes post-procedural right heart catheterization to identify the heart rate that produces the lowest mean pulmonary capillary wedge pressure or the highest cardiac output, which is then programmed as the lower rate limit. The conventional group has the lower rate set to 60 bpm. Clinical status, including Kansas City Cardiomyopathy Questionnaire score, and hemodynamic parameters are compared over a 12-month follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:

  1. Sick sinus syndrome with or without impaired atrioventricular conduction
  2. Persistent or permanent atrial fibrillation with slow ventricular response
  3. Chronotropic incompetence
* Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following:
* H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5
* N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL (sinus rhythm) or ≥ 600 pg/mL (atrial fibrillation)
* Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms

Exclusion Criteria:

* Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing.

(Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.)

* Patients not expected to achieve sufficient pacing dependency, defined as:

  1. In sinus rhythm: baseline atrial rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring
  2. In atrial fibrillation/flutter: baseline ventricular rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring
* Patients with contraindications to permanent pacemaker implantation
* Patients with moderate or greater valvular stenosis or regurgitation.
* Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions
* Pregnant or breastfeeding women.
* Patients who have refused active treatment.

Where it's running

• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Juwon Kim, MD
• Email: abcd186a@naver.com
• Phone: 82-10-2079-8154

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

  This registry tests BIOTRONIK’s CSP-based pacing lead in patients needing a pacemaker or CRT, to see how it performs in real-life use.

  Recruiting at 12 sites Biotronik SE & Co. KG · Adelaide and 45 other locations · NCT07393009

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Ultra-high-frequency ECG to diagnose ventricular electrical dyssynchrony in patients getting pacemakers

  This test checks whether an ultra-high-frequency ECG can safely and accurately detect ventricular dyssynchrony in adults with bradycardia or heart failure who are having their first pacemaker implanted.

  Recruiting at 12 sites VDI Technologies · Avondale, Arizona and 11 other locations · NCT06641362

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Evaluating His Bundle Pacing for Heart Conditions

  This study is testing if special pacing techniques during pacemaker implantation can help improve heart function in people with heart failure or slow heart rates.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT03008291

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.