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Procedure

AAI-DDD 50 followed by DDD-50 for First-degree heart block

N/A
Recruiting
Research Sponsored by Ascension Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 or above
New York Heart Association (NYHA) class II-IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after pacemaker implantation.
Awards & highlights

Study Summary

This trial aims to find out if a certain type of pacing can help improve symptoms and outcomes in patients with a specific heart condition called symptomatic first-degree heart block.

Who is the study for?
This trial is for individuals with symptomatic first-degree heart block, which means their hearts have a specific type of electrical delay. Participants must meet certain health criteria to join, but the provided information does not specify these details.Check my eligibility
What is being tested?
The study is testing whether a special pacing program can help people with this heart condition. It involves implanting a Medtronic pacemaker and setting it to either DDD-50 or AAI-DDD 50 pacing programs to see if symptoms improve.See study design
What are the potential side effects?
While specific side effects are not listed, generally pacemaker implantation can cause infection at the site of surgery, bleeding, bruising or swelling. There may also be risks related to how the device affects heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My heart condition limits my physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after pacemaker implantation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after pacemaker implantation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Secondary outcome measures
Atrial fibrillation burden
Exercise capacity
Patient activity

Trial Design

2Treatment groups
Experimental Treatment
Group I: DDD-50 followed by AAI-DDD 50Experimental Treatment3 Interventions
Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50.
Group II: AAI-DDD 50 followed by DDD-50Experimental Treatment3 Interventions
Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50.

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,635 Total Patients Enrolled
Ascension HealthLead Sponsor
25 Previous Clinical Trials
3,046 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants currently under investigation in this clinical study?

"The trial, as per clinicaltrials.gov, is actively seeking participants. It was initially listed on 10/1/2023 and most recently modified on 1/29/2024. Recruiting efforts are focused on enrolling 40 patients at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Physiologic Pacing for Symptomatic First-Degree Heart Block
Daniel Kaiser 2023. "Physiologic Pacing for Symptomatic First-Degree Heart Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245304.
All > Nashville
~23 spots leftby Dec 2024
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