Clinical trial NCT03118427: Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sick Sinus Syndrome
Complete Atrioventricular Block
High Degree Second Degree Atrioventricular Block (Disorder)
Bradycardia
Keywords: Fluoroscopy
Pacemaker
Three dimensional
Radiation
Imaging
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Xinyang Central Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Guangdong Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: Ningbo No. 1 Hospital
First posted: 2017-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success rate
timeFrame: 3 months
Secondary outcomes:
measure: Total procedure time
timeFrame: during procedure
measure: Fluoroscopy time
timeFrame: during procedure
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Yan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
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