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Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

NCT02145351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-04-05

Study results available
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Summary

Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).

Conditions

  • Heart Failure With a Preserved Ejection Fraction
  • Heart Failure, Diastolic
  • Chronotropic Incompetence

Interventions

DEVICE

Rate adaptive atrial pacing using a dual-chamber pacemaker

The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.

DEVICE

Pacemaker system will be implanted but set to Pacing Off.

The identical pacing system will be implanted, but will be set to Pacing Off.

Sponsors & Collaborators

Principal Investigators

  • Barry Borlaug, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-07
Primary Completion
2022-05-09
Completion
2022-05-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145351 on ClinicalTrials.gov