NCT01700244

Brief Summary

An evaluation of a safety and performance of a new cardiac pacemaker

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

October 2, 2012

Last Update Submit

June 25, 2013

Conditions

Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) BlockNormal Sinus Rhythm With 2 or 3° AV or BBB BlockSinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings

Outcome Measures

Primary Outcomes (1)

  • Complication rate, where a complication is defined as a serious adverse device effect (SADE)

    90 days

Study Arms (1)

Pacemaker

EXPERIMENTAL
Device: Pacemaker implant

Interventions

Pacemaker implantDEVICE
Pacemaker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must have one of the following clinical indications:
  • Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; 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;
  • Subject has life expectancy of at least one year;
  • Subject is not enrolled in another clinical investigation;
  • Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
  • Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC;
  • If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.

You may not qualify if:

  • Pacemaker dependent;
  • Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
  • Hypersensitivity to \< 1 mg of dexamethasone sodium phosphate;
  • Mechanical tricuspid valve prosthesis;
  • Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
  • Pre-existing pacing or defibrillation leads;
  • Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT);
  • Presence of implanted vena cava filter;
  • Presence of implanted leadless cardiac pacemaker;
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Na Homolce Hospital

Prague, Prague, 15000, Czechia

Location

IKEM

Prague, 140 21, Czechia

Location

Kerckhoff Clinic

Bad Nauheim, 61231, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Heart Hospital Munich

Munich, 80636, Germany

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3430, Netherlands

Location

UMC Utrecht

Utrecht, 3584, Netherlands

Location

Related Publications (3)

  • Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.

    PMID: 27932427DERIVED

  • Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.

    PMID: 25881930DERIVED

  • Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.

    PMID: 24664277DERIVED

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Johannes Sperzel, MD

    Kerckhoff Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

CZ(2)DE(3)NL(3)