Clinical trial NCT02698670: Prospective Registry on User Experience With The Mapping System For Ablation Procedures
Official title: Prospective Registry on User Experience With The Mapping System For Ablation Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmias
Keywords: Cardiac Arrhythmias
Cardiovascular Disease
Radiofrequency Ablation
Cardiac Mapping
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 577
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion

Brief summary: This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

Detailed description: The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system.

The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.

Eligibility criteria: Inclusion Criteria:

* Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
* Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Subjects requiring de novo ablation of atrial fibrillation;
* Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility\*;
* The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
* Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
* Unrecovered/unresolved Adverse Events from any previous invasive procedure;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

Primary outcomes:
measure: Acute Procedural Success
timeFrame: At the end of the index procedure (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Orange
country: United States
facility: Hoag Memorial Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: New York
country: United States
facility: Maimonidies Hospital
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital of the University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Riverside Methodist - Ohio Health
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Heart Rhythm Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Memphis
country: United States
facility: Baptist Memorial Hosptial
state: Tennessee
city: Tyler
country: United States
facility: Trinity Mother Francis
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Brisbane
country: Australia
facility: Wesley Medical Research
state: Queensland
city: Pessac
country: France
facility: CHU de Bordeaux
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
city: Hamburg
country: Germany
facility: Universitaetsklinik Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Universität Leipzig
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: London
country: United Kingdom
facility: Harefield Hospital
city: London
country: United Kingdom
facility: The Brompton Hospital
Study officials:
affiliation: Gerhard Hindricks
name: Gerhard Hindricks
role: PRINCIPAL_INVESTIGATOR
References: