The LEADLESS Pacemaker IDE Study (Leadless II) - Full Text View

Purpose

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.

Condition	Intervention
Bradycardia	Device: Leadless Pacemaker


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Complication-Free Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

appropriate and proportional rate response during graded exercise testing [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	667
Study Start Date:	February 2014
Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Leadless Pacemaker VVIR pacing	Device: Leadless Pacemaker Patients will undergo an attempted leadless pacemaker implant

Detailed Description:

The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Subject ≥18 years of age; and
Subject has life expectancy of at least one year; and
Subject is not enrolled in another clinical investigation; and
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
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
Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or
Subject has a mechanical tricuspid valve prosthesis; or
Subject has a pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40 mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40 mmHg), or significant physiologically-impairing lung disease; or
Subject has a pre-existing endocardial pacing or defibrillation leads; or
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
Subject has an implanted vena cava filter; or
Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
Subject has an implanted leadless cardiac pacemaker; or
Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030418

Show 57 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators


Principal Investigator:	Vivik Reddy, MD	Mount Sinai Hospital, New York

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, Friedman PA, Estes NA 3rd, Ip J, Niazi I, Plunkitt K, Banker R, Porterfield J, Ip JE, Dukkipati SR; LEADLESS II Study Investigators. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. 2015 Sep 17;373(12):1125-35. doi: 10.1056/NEJMoa1507192. Epub 2015 Aug 30.


Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT02030418 History of Changes
Other Study ID Numbers:	DC-02374
Study First Received:	January 6, 2014
Last Updated:	November 3, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Bradycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 28, 2016