Ingenio Device Algorithm Study

Boston Scientific Corporation139 enrolled

Overview

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

139

Conditions

Sinus Node Disease AV Block Heart Failure

Interventions

RAATDEVICE

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

RYTHMIQDEVICE

For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study; * Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law; * Subjects indicated for a dual chamber pacemaker or a CRT-P device according to class I or class II indications of the standard ESC or ACC / AHA implant guidelines; * Subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, CRT-P: atrial, right and left ventricular lead) or are already implanted with such leads; * Subjects who receive or are implanted with a bipolar atrial lead. Exclusion Criteria: * Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion); * Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect * Schedule of procedures for IVORY (i.e. should not cause additional or missed visits); * Programming of devices for IVORY per CIP; * IVORY outcome (i.e. involve medications that could affect the heart rate of the subject); * Conduct of IVORY per GCP / ISO 14 155:2011 / local regulations. * Subjects who live at such a distance from the clinic that travels for FU visits at a study center would be unusually difficult or burdensome for the subject; * Inability or refusal to comply with the FU schedule; * A life expectancy of less than 12 months, per physician discretion; * Subjects who are planned to be programmed to a pacing mode other than DDD / DDDR during the study period.

Locations (21)

Wilhelminenspital

Vienna, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Outcomes

Primary Outcomes

Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)

Accuracy was evaluated by the proportion of tests resulting in an RAAT commanded threshold with \|Manual unipolar threshold - commanded threshold\| ≤ 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the manual unipolar threshold and the commanded threshold obtained at a visit.

Time frame: 3 months post implant

System-related Complication-free Rate

Time frame: 90 days post-implant

Secondary Outcomes

Accuracy of Ambulatory RAAT

Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population (pacemaker and CRT-P). Accuracy was evaluated by the proportion of tests resulting in an RAAT ambulatory threshold with \|ambulatory threshold - commanded threshold\| ≤ 1.0V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted consisted of the ambulatory threshold obtained within 7 days prior to the visit and the commanded threshold obtained at the visit.

Time frame: 3 months post-implant

Data from ClinicalTrials.gov

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