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Evaluation of Rate Adaptive Pacing on Chronotropic Response in Preserved Ejection Fraction HF

NCT03160625 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-04-19

No results posted yet for this study

Summary

RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over design. The purpose of the study is to investigate if rate adaptive pacing has the potential to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF patients. Findings from this pilot study may be used to guide subsequent efforts to design and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement in patient outcomes.

Conditions

Interventions

DEVICE

Rate Adaptive Pacing

Rate Adaptive Pacing varies the pacing rate in response to the patient's physical motion as detected by an activity sensor.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Aida Cicic, MD · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-04-30
Completion
2018-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03160625 on ClinicalTrials.gov