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Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

NCT02441101 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-06-18

Study results available
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Summary

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

Conditions

Interventions

DEVICE

RV DDD(R)-60 with AV optimization

Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG

DEVICE

RV DDD(R)-60

AV settings programmed to minimize RV pacing - standard demand pacing programming.

Sponsors & Collaborators

  • Barry London

    lead OTHER

Principal Investigators

  • Michael C Giudici, MD · University of Iowa

  • Michael C Giudici, MD · University of Iowa

  • Shubba D Roy, MD · University of Iowa

  • Trisha Elliott, RTR · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2020-02-11
Completion
2020-02-11

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 NCT02441101 on ClinicalTrials.gov