Clinical trial NCT04919733: Fluoroscopy Reduction or Elimination in CIED Implants
Official title: Fluoroscopy Reduction or Elimination in CIED Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bradycardia
Tachycardia, Ventricular
Heart Failure
Keywords: CIED implant
Fluoroscopy reduction
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To ascertain if the use of 3-D mapping systems reduces the need of fluoroscopy during a CIED (pacemaker or defibrillator) implant
Primary purpose: TREATMENT

Brief summary: CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants

Detailed description: Patients with either brady arrhythmias, tachyarrhythmias, heart failure or primary prevention of sudden death receive a cardiac implantable electronic device (CIED) as a standard of care based on guideline indications. All implants require X-ray equipment to visualize the advancement and positioning of leads in different heart chambers. To date only anecdotical cases have been reported in the literature, of implants without fluoroscopy, mostly pregnant patients with a CIED indication that could not wait for implant after delivery or some rare situations where ultrasound was used to guide the leads trough the heart.

There are two reported experiences using St-Jude Abbot 3-D NavX system; where 35 (ICD and pacemakers) and 15 (VVI pacemakers only) CIED patients were respectively approached with times reported to right ventricular lead implant of 18 +/- 22 minutes and atrial lead implant of 16 +/- 9 minutes, in 89% of cases a final fluoroscopy shot was deemed necessary (in 16% of patients it was needed to correct final position); in the second report with VVI only pacemakers, the implant of a single lead was 10.1 +/- 5.4 minutes, and the total procedure duration was 59.3 +/- 15.16 minutes -one patient needed fluoroscopy-, this last cohort was compared to previous 15 VVI pacemaker patients implanted under fluoroscopy, with control times of 51.5 +/- 12.3 minutes6 (p=ns); both studies reported around 10 minutes needed to obtain right chamber anatomies. There is a little more experience on biventricular implants with two reports one single center and then the same Italian group with a multicenter study achieving a significant reduction in fluoroscopy times: from 16 minutes to 4 minutes (ranges from 11-26 to 0.3-10.4 minutes) compared with a historical control, and with the same success rates to left lead implants; even in experienced centers (more than 10 previous implants) the median time was 3 minutes of fluoroscopy when a St-Jude Abbot NavX system was used.

The advancement on 3-D mapping systems, allows nowadays to reduce and even eliminate the need of X-rays for most of ablation procedures, where the catheters advancement, positioning and navigation through the four heart chambers is accomplished with minimal or no irradiation to the patients and to the health care personnel.

The hypothesis is that use of standard 3-D mapping systems to achieve CIED implants is feasible, safe, and that could be accomplished in a time efficient way. This will be the first large report for all type of CIED implants and with all available 3-D mapping system utilization; the investigators will try also to define if a complete reconstructed virtual anatomy is needed of if a rough anatomy is sufficient to achieve the implant, and speed procedure times.

Eligibility criteria: Inclusion Criteria:

* CIED implants

Exclusion Criteria:

* Patients with an urgent life-threatening indication requiring an urgent CIED implant.
* Patients with known venous system abnormalities (as venous occlusion or abandoned non-accessible leads).

Primary outcomes:
measure: Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure
timeFrame: During implant procedure
measure: Peak skin dose of radiation exposure during CIED implant
timeFrame: During implant procedure
measure: Radiation exposure (kerma-area product) during CIED implant
timeFrame: During implant procedure
measure: Total procedural time
timeFrame: During implant procedure
measure: Safety issues arising because of reduction of fluoroscopy
timeFrame: During implant procedure
Secondary outcomes:
measure: Detailed 3-D mapping needed Y/N
timeFrame: During implant procedure
measure: Current of lesion at desired implant fixation site (Y/N)
timeFrame: During implant procedure
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
state: Quebec
Study officials:
affiliation: University of Shebrooke Medical School
name: Felix AYALA PAREDES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: