Fluoroscopy Reduction or Elimination in CIED Implants

Heart Failure Clinical Trial

Official title:

Fluoroscopy Reduction or Elimination in CIED Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919733
• Other study ID #: 2019-3060
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: March 3, 2024

Study information

• Verified date: May 2022
• Source: Université de Sherbrooke
• Contact: Felix AYALA PAREDES, MD, PhD
• Phone: 819 346 1110
• Email: felix.ayala-paredes[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• Fluoroscopy reduction
To decrease, using 3-D mapping systems, the amount of fluoroscopy needed to implant a CIED

Locations

Country	Name	City	State
Canada	CHUS Fleurimont	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure	Fluoroscopy time while implanting a CIED	During implant procedure
Primary	Peak skin dose of radiation exposure during CIED implant	Radiation exposure expressed as total Cumulative Air Kerma (mGy)	During implant procedure
Primary	Radiation exposure (kerma-area product) during CIED implant	Total Dose Area Product (uGy-m2)	During implant procedure
Primary	Total procedural time	Time of the patient entering the lab, to the time the patient exits the lab	During implant procedure
Primary	Safety issues arising because of reduction of fluoroscopy	Complications arising while using a reduced fluoroscopy environment	During implant procedure
Secondary	Detailed 3-D mapping needed Y/N	Is it necessary to create a detailed anatomy to navigate leads without fluoroscopy	During implant procedure
Secondary	Current of lesion at desired implant fixation site (Y/N)	If current of lesion is necessary to ascertain that the fixation mechanism is already deployed	During implant procedure