Trial Outcomes & Findings for Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function (NCT NCT01513538)

Results Overview

The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians. Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.

Recruitment status

COMPLETED

Target enrollment

700 participants

Primary outcome timeframe

30 months

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Implanted With a Dual Chamber Pacemaker All the enrolled patients were patients implanted with a dual chamber pacemaker with the Therapy Guide application : one-arm study.
Overall Study STARTED	578
Overall Study COMPLETED	573
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TherapyGuide n=578 Participants Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function TherapyGuide: Use of TherapyGuide function to help programming the device
Age, Customized Men	77 years n=5 Participants
Age, Customized Women	79 years n=5 Participants
Sex/Gender, Customized Men	347 participants n=5 Participants
Sex/Gender, Customized Women	231 participants n=5 Participants
Region of Enrollment France	578 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 months

The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians. Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.

Outcome measures

Outcome measures
Measure	Patients Implanted With a Dual Chamber Pacemaker n=573 Participants All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.
Acceptance of TherapyGuide Proposals and Typology of Programming Changes	46 percentage of patients

Adverse Events

Patients Implanted With a Dual Chamber Pacemaker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Céline This

Medtronic

Phone: 33 6 89 71 90 67

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place