Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

Study Overview
=================
Brief Summary
-----------------
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.

Detailed Description
-----------------
Permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.

Official Title
-----------------
Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

Conditions
-----------------
Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block (Disorder), Bradycardia

Intervention / Treatment
-----------------
* Procedure: zero-fluoroscopy 3D navigation
* Procedure: conventional x-ray navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sick Sinus Syndrome complete Atrioventricular Block high degree second Degree Atrioventricular Block Bradycardia Exclusion Criteria: pacemaker replacement severe structural cardiac malformations severe cardiac enlargement venous malformations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero-fluoroscopy implantation<br>Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation. | Procedure: zero-fluoroscopy 3D navigation<br>* Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.<br>* Other names: non-fluoroscopy 3D navigation;|
| Active Comparator: Conventional fluoroscopy implantation<br>Pacemaker implantation performed for all patients with conventional x-ray navigation. | Procedure: conventional x-ray navigation<br>* Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.<br>* Other names: fluoroscopy navigation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time |  | during procedure | 
| Fluoroscopy time |  | during procedure | 
| Complications |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging