Higher pacemaker rate for people with cardiac amyloidosis

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 single-center interventional pilot will enroll 10 adults with cardiac amyloidosis who have implanted pacemakers. Investigators will temporarily raise the programmed pacing rate and compare heart-failure symptoms and exercise tolerance before and after the rate change. Eligible patients must have a non-dilated left ventricle and appropriate pacemaker modes (AAI, DDD, or VVI for permanent atrial fibrillation), while those with paced QRS >150 ms or a dilated LV are excluded. All procedures and outcome measurements are performed in person at the University of Minnesota using standardized symptom and exercise assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults 18 and older
* Diagnosis of cardiac amyloidosis as indicated by the criteria set forth in guidelines such as in Kittleson et al: "2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis: A Report of the American College of Cardiology Solution Set Oversight Committee
* Implanted Cardiac Pacemaker (+/- Defibrillator)
* Pacemaker mode of AAI or DDD if in sinus rhythm, VVI acceptable if permanent atrial fibrillation
* Non-dilated left ventricle by echocardiography
* Ability to provide written consent
* English Speaking

Exclusion Criteria:

* Paced QRS duration of \>150 ms (indicator for pacing mediated dyssynchrony)
* Dilated left ventricle

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Valmiki Maharaj — University of Minnesota
• Study coordinator: Meghan Muscala
• Email: payne324@umn.edu
• Phone: 612-626-5863

Similar studies

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

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• Liver and Coagulation Markers in ATTR Cardiac Amyloidosis

  This study tests liver function and blood-clotting markers in people with ATTR-CA to see if they reflect disease severity and progression.

  Recruiting University of Messina · Messina, Sicily · NCT07766135

• Cardiac Amyloidosis: See if Intracardiac Thrombi are Common on CT

  This study tests whether a contrast-enhanced cardiac CT can reliably detect intracardiac thrombi in adults with cardiac amyloidosis.

  Recruiting Centre Hospitalier Universitaire Dijon · Dijon · NCT07648303

• Using [64Cu]FBP8 PET/MR to find intracardiac blood clots in cardiac amyloidosis

  We'll test whether a [64Cu]FBP8 PET/MR scan can find blood clots inside the heart of people with cardiac amyloidosis who have atrial fibrillation or atrial flutter.

  Recruiting Phase 3 Brigham and Women's Hospital · Boston, Massachusetts · NCT07560306

• Chest pain screening for hidden cardiac amyloidosis

  We will test whether men over 65 who have chest pain but no coronary artery disease might have hidden cardiac amyloidosis using blood and urine tests, ECG and echocardiography, bone scintigraphy, and sometimes a heart biopsy.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07435168

• Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

  This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.

  Recruiting Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · Bad Oeynhausen, North Rhine-Westphalia · NCT07342036

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.