Bradyarrhythmia Clinical Trial
— PACMANOfficial title:
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
| NCT number | NCT01897558 |
| Other study ID # | GER-EP-012 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | December 2014 |
| Verified date | March 2023 |
| Source | Deutsches Herzzentrum Muenchen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.
| Status | Completed |
| Enrollment | 290 |
| Est. completion date | December 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - de-novo implantation of a pacemaker system Exclusion Criteria: - AAI pacing or cardiac resynchronization therapy - ICD indication - temporary pacing - lead revision - right ventricular pacing aimed from alternative pacing sites (other than the apex) - lead revision - severe tricuspid valve regurgitation - previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels - dialysis |
| Country | Name | City | State |
|---|---|---|---|
| Croatia | University Hospital Dubrava | Zagreb | |
| Germany | Klinikum Kempten | Kempten | |
| Germany | Krankenhaus Landshut-Achdorf | Landhut | |
| Germany | Deutsches Herzzentrum München | München | |
| Japan | Kenri Hospital | Mishima |
| Lead Sponsor | Collaborator |
|---|---|
| Deutsches Herzzentrum Muenchen |
Croatia, Germany, Japan,
Blazek P, Ferri-Certic J, Vrazic H, Lennerz C, Grebmer C, Kaitani K, Karch M, Starcevic B, Semmler V, Kolb C. Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads. Sci Rep. 2018 Mar 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | high-sensitive Troponin T | 1 day |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00976482 -
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
|
N/A | |
| Completed |
NCT01089634 -
Left Ventricular Capture Management Study
|
||
| Completed |
NCT02930980 -
Micra Accelerometer Sensor Study 2
|
N/A | |
| Recruiting |
NCT03693157 -
The Safety and Efficacy of FFR Protocol in NTUH System
|
||
| Completed |
NCT05357716 -
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
|
||
| Recruiting |
NCT05585411 -
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
|
N/A | |
| Completed |
NCT01522755 -
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
|
||
| Completed |
NCT01513538 -
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
|
N/A | |
| Completed |
NCT05997004 -
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
|
N/A | |
| Recruiting |
NCT04905199 -
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
|
||
| Recruiting |
NCT05401851 -
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
|
N/A | |
| Not yet recruiting |
NCT04437901 -
COVIDAR - Arrhythmias in COVID-19
|
||
| Terminated |
NCT01535404 -
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
|
N/A | |
| Completed |
NCT01523704 -
Safety and Efficacy Study of IPG Patient With Home Monitoring
|
N/A | |
| Recruiting |
NCT06324682 -
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
|
||
| Completed |
NCT01715558 -
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
|
N/A | |
| Recruiting |
NCT01310907 -
Identify the Genes Polymorphisms Related to Non-familial Bradyarrhythmia
|
N/A | |
| Recruiting |
NCT04697797 -
Mechanical and Electrical Dyssynchrony During His-Bundle Pacing Versus His-Bundle Area Right Ventricular Pacing
|
||
| Recruiting |
NCT04831125 -
Conduction System Pacing International Registry (CONSPIRE)
|