A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation

M

MediCool Technologies

Status

Not yet enrolling

Conditions

Atrial Fibrillation

Treatments

Other: Cool therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05324540
FIH-001

Details and patient eligibility

About

An assessment of the use of cold therapy to terminate atrial fibrillation.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Subject must be ≥ 18 years or older
  • Male of female
  • Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration
  • Must be in AF at time of surgery, or inducible using manual or electrical stimulation
  • Subject is willing and able to provide written informed consent
  • Subject has a life expectancy of at least 1 yearExclusion Criteria:

Exclusion Criteria: • Long-standing AF (duration > 1 year)

  • Prior AF ablation
  • Left main coronary artery occlusion > 70%
  • Critical aortic stenosis (gradient > 50mm HG)
  • Inability to induce patient into AF without drugs at time of surgery
  • Female subjects who are pregnant at time of surgery
  • Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study
  • Permanent pacemaker or implantable cardioverter defibrillator
  • Current cancer treatment that includes radiation of the heart
  • Inability to give informed consent
  • Significant intra-cardiac thrombus
  • Subjects not eligible for or considered high risk for anticoagulation

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Cool therapy
Experimental group
Description:
A chilled instrument that has been chilled to a proscribed temperature will be applied to the oblique sinus. The instrument may be applied for up to 3 minutes per application and up to 3 times per patient.
Treatment:
Other: Cool therapy

Trial contacts and locations

0

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Central trial contact

Jeff Rynbrandt

Data sourced from clinicaltrials.gov

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