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Pacemaker

Leadless Pacemaker for Slow Heart Rate

N/A
Waitlist Available
Led By Vivik Reddy, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has life expectancy of at least one year;
Subject is not enrolled in another clinical investigation;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication-Free Rate
Pacing thresholds and R-wave amplitudes within the therapeutic range
Secondary outcome measures
appropriate and proportional rate response during graded exercise testing

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leadless PacemakerExperimental Treatment1 Intervention
VVIR pacing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leadless Pacemaker
2014
N/A
~530

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
636 Previous Clinical Trials
403,225 Total Patients Enrolled
Vivik Reddy, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
2014. "The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02030418.
~47 spots leftby Apr 2025
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