AdaptResponse Clinical Study

JRCT ID: jRCTs052180128

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 10/11/2014
• Target sample size: 82
• Countries of recruitment: Australia,Japan,Canada,Japan,Hungary,Japan,Slovakia,Japan,Austria,Japan,Belgium,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Portugal,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,United Kingdom,Japan,Iceland,Japan,Russian Federation,Japan,India,Japan,Korea,Japan,Mexico,Japan,Saudi Arabia,Japan,Kuwait,Japan,United Arab Emirates,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Treatment group (aCRT ON, with AdaptivCRT programmed to Adaptive Bi-V and LV)
Control group (aCRT OFF, with AdaptivCRT programmed to Nonadaptive CRT)

Outcome(s)

• Primary Outcome: To test the hypothesis that AdaptivCRT reduces the incidence of the combined endpoint of all-cause mortality and intervention for heart failure decompensation, compared to standard CRT therapy, in patients with a CRT indication, LBBB and normal AV conduction.
• Secondary Outcome: To test the hypothesis that aCRT ON reduces all-cause mortality compared to aCRT OFF etc.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Subject is willing to sign and date the study Patient Informed Consent (PIC) Form.
2 Subject is indicated for a CRT device according to local guidelines.
3 Sinus Rhythm at time of enrollment.
4 Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Criteria16 for complete LBBB must include:
-Intrinsic QRS duration >=140 ms (men) or >=130 ms (women), -QS or rS in leads V1 and V2
-Mid-QRS notching or slurring in >=2 of leads V1, V2, V5, V6, I, and aVL.
5 Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
6 Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
7 NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

Exclude criteria

1 Subject is less than 18 years of age (or has not reached minimum age per local law).
2 Subject is not expected to remain available for at least 2 years of follow-up visits.
3 Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
4 Subject is, or previously has been, receiving cardiac resynchronization therapy.
5 Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
6 Subject has unstable angina or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
7 Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
8 Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
9 Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
10 Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
11 Subject meets any exclusion criteria required by local law.

Related Information

• Primary Sponsor: Kusano Kengo
• Secondary Sponsor: Hidaka kazuhiro,Medtronic Japan Co., Ltd.,Medtronic Japan Co., Ltd.
• Secondary ID(s): UMIN000015371