Trials Sponsors Conditions Drugs Pricing

Conditions

AtrioVentricular Nodal Reentrant Tachycardia Heart Disease Supraventricular Tachycardia

Keywords

Cardiac cryoablationAVNRTheart diseasetachycardiaAtrioVentricular Nodal Reentrant TachycardiaSupraventricular tachycardiaSVT

Outcome Measures

Primary Outcomes (2)

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: * Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. * Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.
6 months
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.

Study Arms (1)

Cryoablation

EXPERIMENTAL

Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.

Device: Freezor Xtra Cryoablation Catheter

Interventions

Freezor Xtra Cryoablation CatheterDevice

Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.

Cryoablation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

You may not qualify if:

Sponsors & Collaborators

Medtronic Cardiac Ablation Solutions
Industrylead

Study Sites (34)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Pacific Heart Institute

Santa Monica, California, 90404, United States

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Related Publications (1)

Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.
PMID: 29044787DERIVED

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal ReentryTachycardia, SupraventricularHeart DiseasesTachycardia

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingArrhythmias, CardiacCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Jo Krueger, Senior Clinical Research Specialist
Organization: Medtronic

Study Officials

Peter Wells, M.D.
Baylor Univ Medical Ctr Dallas, TX.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

572 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

May 2012

Date type not reported

This date has not been verified as actual or estimated.

Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Cryoablation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Cryoablation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Source record

Locations