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Recruiting NCT07583823

Elevated Rate Pacing of Cardiac Amyloidosis

No phase Interventional Cardiac Amyloidosis Pacemaker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pacemaker Rate.
Who it may be relevant to
Registry conditions: Cardiac Amyloidosis, Pacemaker. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.

Interventions

  • Other Pacemaker Rate
    CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.

Primary outcome measures

  • Kansas City Cardiomyopathy Questionnaire Score [Time frame: Month 4]
  • Composite of any cardiovascular event [Time frame: Month 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07583823 · CV-2025-33753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗