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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02030418




Registration number
NCT02030418
Ethics application status
Date submitted
6/01/2014
Date registered
8/01/2014
Date last updated
19/12/2022

Titles & IDs
Public title
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Scientific title
The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
Secondary ID [1] 0 0
DC-02374
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Leadless Pacemaker

Experimental: Leadless Pacemaker - VVIR pacing


Treatment: Devices: Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complication-Free Rate
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Pacing thresholds and R-wave amplitudes within the therapeutic range
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
appropriate and proportional rate response during graded exercise testing
Timepoint [1] 0 0
3-6 months

Eligibility
Key inclusion criteria
1. Subject must have one of the clinical indications before device implant in adherence
with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

- Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular
bundle branch block (BBB block), including slow ventricular rates (with or
without medication) associated with atrial fibrillation; or

- Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical
activity or short expected lifespan (but at least one year); or

- Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings;
and

2. Subject =18 years of age; and

3. Subject has life expectancy of at least one year; and

4. Subject is not enrolled in another clinical investigation; and

5. Subject is willing to comply with clinical investigation procedures and agrees to
return for all required follow-up visits, tests, and exams; and

6. Subject has been informed of the nature of the study, agrees to its provisions and has
provided written informed consent, approved by the IRB; and

7. Subject is not pregnant and does not plan to get pregnant during the course of the
study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in
arterial blood pressure with the onset of ventricular pacing; or

2. Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or

3. Subject has a mechanical tricuspid valve prosthesis; or

4. Subject has a pre-existing endocardial pacing or defibrillation leads; or

5. Subject has current implantation of either conventional or subcutaneous implantable
cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or

6. Subject has an implanted vena cava filter; or

7. Subject has evidence of thrombosis in one of the veins used for access during the
procedure; or

8. Subject has an implanted leadless cardiac pacemaker; or

9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of
enrollment

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2022
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
State/province [29] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, non-randomized, single-arm, international multicenter, clinical safety and
effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR
pacemaker.

Following completion of enrollments in the IDE, patients will continue to be enrolled in the
continued access phase of the study under the same protocol.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02030418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vivik Reddy, MD
Address 0 0
MOUNT SINAI HOSPITAL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02030418