Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

NCT ID: NCT01981590

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-09-30

Brief Summary

The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.

Detailed Description

Purpose The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins.

Study Design This is a prospective, non-randomized, acute feasibility study.

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All enrolled patients

All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice

Group Type: EXPERIMENTAL

Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.

Intervention Type: DEVICE

Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.

Interventions

Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.

Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects older than 18 years of age
• Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures and/or device implant.
• Subjects willing and able to give informed consent

Exclusion Criteria

• Subject with a previously implanted transvenous lead, which is still present in the veins under study.
• Subject with evidence of phrenic nerve palsy.
• Subject with chronic obstructive pulmonary disease.
• Subject with a spinal cord stimulator.
• Subject needs to receive drugs that might interfere with patient perception.
• Subjects with medical conditions that would prevent study participation
• Subjects who are pregnant, nursing, or of child bearing potential and are not on a reliable form of birth control
• Subjects enrolled in concurrent studies which could confound the results of this study
• Subject is unable or unwilling to participate with study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frieder Braunschweig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, department of Cardiology

Locations

Stichting Catharina Ziekenhuis

Eindhoven, EJ, Netherlands

Karolinska University Hospital, Solna

Stockholm, , Sweden

Countries

Netherlands; Sweden

Other Identifiers

MAPs-breathing

Identifier Type: -

Identifier Source: org_study_id